Archive for the ‘Stem Cell Clinic’ Category

FDA Response – U.S. Stem Cell Clinic

Stem Cell Clinic | Posted by admin
Jun 29 2018

RE: Warning letter received August 24th, 2017

Dear Mr. Randall Morris,

Please accept this letter as response to the warning letter received August 24th, 2017. In sum, as was previously demonstrated, the US Stem Cell Clinic (USCC) is not utilizing a biological drug product and therefore the regulations of part 210 and 211 (current good manufacturing practices) do not apply. The comments in the provided warning letter are specific to products that are produced in cGMP manufacturing facilities and classified as drugs according to the FDA. This is not something that a medical clinic would be required to follow. USCC is not manufacturing a drug. That being said, in an abundance of caution, US Stem Cell Clinic will immediately switch to 510(k) approved systems to process tissue in clinic such as bone marrow systems and/or fat systems.

Our facility has demonstrated sterile surgical techniques as required by the medical boards. It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures including using individually wrapped disposable sterile supplies, sterile field prep, and more. The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals. As a clinic performing a medical procedure, we have strict and appropriate protocols in place to prevent contamination and breach of sterility. We are following the exact protocols that are utilized at surgical centers and hospitals. As you know, these protocols are very different than what is required for GMP manufacturing facilities. We have never had an incidence of contamination and the statements that were made in your warning letter and press release are misleading and causing irreparable harm.

We have previously described in detail why the FDA has wrongly defined these in clinic procedures as a drug and provided evidence. The evidence and summary is provided below. I would like to specifically call your attention to the fact that according to your current code of federal regulations, same surgical procedure is not subject to the rules for tissue banks which include minimal manipulation and homologous use. We strongly believe that it is a violation of the rights of American citizens to prevent them from seeking alternative care for their conditions as long as it does not violate regulations or the law. Our clinic is not violating the law as it is currently written. There is huge support from government officials and American citizens for stem cell treatmentsagain, while all laws are adhered to as we do. Please refer to just one petition out of many regarding stem cell treatments in clinic with almost 70,000 signatures:

We would also like to address the comment in your warning letter regarding our firm impairing the ability to conduct the inspection. This statement is blatantly false and should be removed from the record. We provided access to every room in the facility and allowed pictures on multiple occasions. We also provided copies of all requested documents including confidential patient information. We are an extremely small firm with only a handful of employees most of which are part time or 1099 contract. As a small firm with limited resources, it is necessary to schedule the access that was required by the investigators in order to prevent permanent damage to our business. We provided abundant time and availability to the inspectors and on several occasions, the inspectors canceled last minute and did not come. At one point, the inspectors came to the office when the office was closed. During this last inspection, we worked with the inspectors for over a month providing hundreds of copies and burned CDs. On several occasions, I requested paper, printer ink and office supplies but did not receive what was requested. This inspection caused undue financial harm to our small firmyet we made our staff and resources available to the investigators at all times. Stating that we prevented or limited access to our company is an apparent attempt to disparage our company and we deem it both unprofessional and an unfair statement.

Given that we are a medical clinic that does not manufacture drugs, the guidance document that you referenced does not apply to our facility. Instead, USCC is performing a medical procedure wherein tissue is removed from a patient and re-implanted during the same surgical procedure. 21 C.F.R. 1271(b) titled Human Cells, Tissues and Cellular Tissue-Based Products, expressly states, you are not required to comply with the requirements of this part if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.

The procedure performed at USSC is simply the practice of medicine. Medical practitioners have been performing similar type procedures in clinic for decades including fat, skin, tendon/ligament, vascular, hair and bone grafts, bone marrow transplantation, and blood/plasma transplantation. Please keep in mind that many of these medical procedures may involve non-homologous use of tissue (CABG with vein graft or ileum to replace bladder) or more than minimal manipulation (skin grafts, hair transplants, or bone grafts). But because these are completed by medical practitioners during the same surgical procedure, the practitioners per the exception clause are not required to comply with the requirements of this part (1271) which includes details on products under section 351 vs. 361 PHS Act.

Therefore, the regulatory sections of Part 1271 regarding homologous use or more than minimal manipulation are not applicable to the procedures performed by USSC. To be clear, the purpose of stem cells inside our bodies is to maintain and repair damaged tissue, therefore any application of stem cells to patients would in fact be defined as homologous.

Even if USSC were somehow subject to the regulatory sections of Part 1271, the protocols utilized by USSC would be exempt from the regulations because the procedures practiced at USSC do not involve more than minimal manipulation. Part 1271 Regulations create a regulatory exemption from the manufacturing and labeling requirements that normally apply to drugs and biological products for any HCT/P that is no more than minimally manipulated. See 21C.F.R. 1271.10(a). Minimal manipulation of cells means processing that does not alter the-relevant biologicalcharacteristics. Id. 1271.3(f)(2).

In the procedures performed at USCC, the actual stem cells are not modified or changed in any way but instead separated via centrifugation. Even the collagenase digestion only changes the integrity of the extracellular matrix and does not change the characteristics of the cells themselves. These scientific facts were confirmed by several leading stem cell scientists at the September 2016 FDA hearing.

Medical procedures are already scrutinized and regulated by the state medical boards, legislatures, and agencies. In addition, the doctor patient relationship is protected and physicians take a vow to protect the safety, health and welfare of patients. They are dedicated to serving the interest of the patient and market forces, societal pressures, and administrative demands must not compromise this promise. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of drugs. The FDA does not regulate the practice of medicine or the bodies/tissues of individuals.

This same procedure is currently performed at thousands of clinics throughout the US. Notably, throughout the stem cell field, these clinics and practitioners also maintain that the procedures performed are medical procedures, and that the regulations of part 210 and 211 (current good manufacturing practices) do not apply.

We are aware that many clinics have been visited by the FDA without any actions or warnings letters. At USCC, we are following standard clinical procedures for medical facilities to ensure safety of the patients. This is considered a medical procedure because the tissue is removed from the patient and re-implanted during the same surgical procedure to the same patient (autologous use). The protocols used at our clinic have been well established in publications as both efficacious and safe. Over ten thousand patients have been treated using similar protocols with a strong safety record. Specifically, over 7000 patients have been treated using the exact same laboratory kit that we utilize at USCC.

Bone marrow and blood products are currently being utilized in the clinic in a similar fashion. The only reason bone marrow products are being regulated differently is because they predate the 1976 medical device amendments allowing for a 510k process instead of IND/IDE. There is no scientific or medical reason that fat tissue removed from a patient would be regulated differently than bone marrow or blood, when they are being used for the same purpose. According to recent publications, cells from fat tissue are demonstrating superior clinical results than bone marrow cells. This is most likely due to the fact that the bone marrow contains very high amounts of white blood cells (WBCs) which can cause unnecessary inflammation whereas fat has low amounts of WBCs. Fat tissue, however, may contain up to 500 times more stem cells. The rate of complications from taking a bone marrow aspirate is significantly higher than taking an adipose sample. The cells that are obtained from an adipose sample are separated from the adipocytes and have not been manipulated or changed in any way prior to reintroducing into a patient. According to reports, these therapies do not have the same negative side effects as many of the available drugs on the market.

We are aware that the FDA received comments on the published draft guidelines regarding adipose tissue procedures in clinic. We are also aware that the FDA held a public hearing regarding these topics in September 2016 in which many scientists, physicians and patients expressed support for these therapies. We are able to provide the FDA with any necessary information to demonstrate that this is a medical procedure that is safely done on an outpatient basis. Published results of outcomes to date have been overwhelmingly positive.

If the federal government were to interfere with a persons ability to obtain and utilize their own cells in their body to heal themselves, this could be a gross violation of the constitution. According to the constitution, Americans have a fundamental right to privacy as well as protection from undue government intrusion. Specifically, in the case of Griswold v. Connecticut 381 U.S. 479, 484-486 (1965), the Supreme Court recognized that specific guarantees in the Bill of Rights create zones of privacy to protect certain intimate activities from means which sweep unnecessarily broadly and thereby invade the area of protected freedoms. Regarding bodily integrity, the court ruled that no right is held more sacred, or is more carefully guardedthan the right of every individual to the possession and control of his own person, free from all restraint or interference from others Both Roe v. Wade, 410 U.S. 113 (1973) and Planned Parenthood v. Casey 506 U.S. 833 (1992), protected rights to privacy, autonomy, and personal choice. See also A.L.A. v. West Valley City, 26 F.3d 989, 990 (10th Cir.1994) (There is no dispute that confidential medical information is entitled to constitutional privacy protection.); According to A. Rahman Ford, JD, PhD, Undue infringement by the federal government upon so sacrosanct a right as the bodily integrity of private persons must be viewed as paternalistic, Victorian and an affront to the freedoms inherent in the Constitution itself.

Notwithstanding the aboveand again, in an abundance of cautionit is our sincerest interest to adhere to the FDAs interpretation of the laws and have several specific questions that we would like the FDA to kindly provide answers to:

Our clinic is simply providing medical treatments to consenting patients using cells from their own body during a medical procedure which does not invoke oversight by the federal government. We would like to specifically request a meeting with the FDA commissioner to better explain the procedures that have successfully helped thousands of people.

We look forward to your responses to our questions above. Feel free to contact me if additional information is required.

FDA Response – U.S. Stem Cell Clinic

World Stem Cell Clinic – For a better quality of life | WSCC

Stem Cell Clinic | Posted by admin
Jun 18 2018

World Stem Cell Clinicoffers themostAdvanced stem cell treatmentsalong with cosmetic, dermatology, and pain management,most of our services are standard approved medical procedures but a few maybe done by World Stem Cell Clinic under a self-funding clinic trial program to qualified patients at the medical facility in Chennai. It provides an opportunity for a better quality of life for the patient. The clinic and laboratory were designed, built and are operated under the stringent guidelines as established by USFederal Regulations Title 21, Subpart C, 211-42 through 211-58,and theUSFederal Drug Administrations Good Laboratory Practice (cGLP)regulations for biologics and clinical laboratories. The Clinic is also ISO 9001:2015 Certified. The strict adherence to these established guidelines and policies guarantees the highest quality of clinical care in all the above mentioned medical treatment safety for the patient. We are proud to have a mission to make stem cell operations transparent so that patients can evaluate and determine their best treatment options with optimal providers. We follow, collect and publish data from our patients for two years or more following treatments. World Stem Cell Clinic brings with it over 6 years of research and treatment history with great results thereby changing many patient lives. World Stem Cell Clinics medical staff and clinical physicians will examine you and review all available medical records, radiology films, CT scans and other diagnostic information to assess if the treatmentcan be performed which in turn help the patient to have a increased quality of life pertaining to the specific condition. Then, the medical doctors meet and confer with the research scientists for a pre-treatment plan. This treatment planning conference takes advantage of decades of the staffs clinical experience, your current condition, your available social support system, full review of your medical history as well as an inclusion and consideration of any recently published research literature on stem cell treatments. In other words, you are provided a detailed, systematic and entirely unique treatment care plan for you or your loved ones needs.

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World Stem Cell Clinic – For a better quality of life | WSCC

Stem Cell Clinic Palmetto – Stem Cell Therapy Greenwood …

Stem Cell Clinic | Posted by admin
Jun 18 2018

Umbilical cord cells include stem cells, growth factors and a range of other beneficial proteins and compounds. We only use umbilical cord blood which has been purified to get rid of any harmful substances that might cause rejection of the treatment by your body. We inject the treated cord blood into the affected area, where the various active compounds found in cord cells go to work immediately to begin inflammation reduction and the promotion of healthy cell division and renewal. Some of the active compounds at work include VEGF (Vascular Endothelial Growth Factor), IL-LRA (Interleukin-1, a receptor antagonist, stem cell factors (SCF), FGF-2 (Fibroblast Growth Factor-2) and Transforming Growth Factor-beta (TGF-beta). Each of these compounds has a slightly different effect, but the net result is that the damaged cells in your joints are given the ingredients they need to kick-start healthy renewal and regeneration. The injection creates a healthier environment that encourages positive, healing changes to take place. A better blood and oxygen supply to the area, a reduction in damaging chronic inflammation and stimulation of healthy tissue growth are all typical consequences of the minimally invasive stem cell treatments we provide. By using umbilical cord cells in this way, its possible to transform joint therapy into a holistic healing process that prompts the body to enhance its own regenerative efforts. This results in a natural process of joint health improvement in the weeks or months following the injection.

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Stem Cell Clinic Palmetto – Stem Cell Therapy Greenwood …

Top Stem Cell Therapy Clinic in Vail & Denver, Colorado …

Stem Cell Clinic | Posted by admin
Sep 20 2017

Do you have an idea of the natural healing potential that is available in your body?

Read on to find out where your body stores these powerful stem cells.

Adult stem cells are found in the highest concentration in adipose (fat) tissue. In smaller concentrations, they are additionally found in your bone marrow. Beyond what is used for harvesting, stem cells are also found in blood, skin, muscles, and organs.

Adipose tissue provides the largest volume of adult stem cells (1,000 to 2,000 times the number of cells per volume found in bone marrow). Bone marrow provides some stem cells but more importantly provides a large volume of growth factors to aid in the repair process. In addition to adult stem cells, fat tissue also contains numerous other regenerative cells that are important to the healing process.

Stem cells derived from adipose fat tissue have been shown to be a much better source for the repair of cartilage degeneration and recent studies have demonstrated its superior ability to differentiate into cartilage.

There are some myths and misconceptions about stem cells and where the cells come from. Dr. Brandt has dedicated a blog post to the important topic.

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Top Stem Cell Therapy Clinic in Vail & Denver, Colorado …

Stem Cell Therapy – American Regenerative Clinic, Stem …

Stem Cell Clinic | Posted by admin
Sep 19 2017

Stem Cell Therapy employs the bodys own healing potential by isolating stem cells from one location of the body (fat tissue or bone marrow) and relocating them to an area of disease, injury, or inflammation. The main function of stem cells is to maintain and repair tissue. Stem Cell Therapy enhances this natural function by getting stem cells more directly to an area of need within the body. As soon, as stem cells get in there, they will grow to type of cells the body needs to be repaired. Stem cells have the unique ability to form many different types of tissue including bone, cartilage, muscle, etc. They are naturally anti-inflammatory, and can therefore help in the bodys own healing process and potentially reverse the effects of many diseases.

Some of the conditions currently being successfully treated include arthritis, sport related injuries, COPD, CHF, CAD, DM, auto-immune disease such as Lupus Erythematosus and Crohns disease, neurological disorders such as multiple sclerosis and Parkinson disease, spinal cord injuries, autism, critical limb ischemia, and many others.

American Regenerative Clinic will perform outpatient procedures using a process in which we isolate a patients own stem cells from either their own adipose (fat) tissue, or bone marrow. After mini-liposuction or bone marrow harvest from pelvic bone under local anesthesia, the patient tissue will be specially processed. Then immediately Isolated Stem Cells will be delivered to the same patient. Depending on nature of the disease, the cells may be injected into the joint, IV, intrathecal (lumbar puncture), intramuscular, or as a combination of above. The entire process will take just a few hours.

In many old injuries and degenerative diseases, a phenomenon called cellular depletion occurs. Because Prolotherapy and PRP rely on the bodys available repair cells locally, these two methods may produce little results. Prolotherapy starts repair process by mobilizing growth factors in the area via lengthy process of multiple injections. PRP brings them right away, but lacks bricks for repair. More advanced Stem Cell Therapy delivers everything the body needs for promising treatment.

Please read the instructions below carefully.

Discontinue Anti-Inflammatory medication (Advil, Motrin, Ibuprofen, Aleve, and Aspirin) at least 3-4 days before your procedure. Discontinue any blood thinners or any herbs, supplements or vitamins 1-2 weeks before your procedure. Discontinue Systemic Steroids (Prednisone, Hydrocortisone, etc.) 1-2 weeks before your procedure. Steroid Injections (cortisone) should be discontinued at least 1 month before your procedure. Eat a light, healthy breakfast the day of your procedure. Drink plenty of water, especially the day of your procedure.

If you have any questions, you are welcome to call our office at 248-876-4242.

Please read the following steps carefully.

0-3 Days Post Stem Cell Therapy: It is highly recommended that the patient rest the day of the procedure. The next two days the patient should focus on keeping the affected joint(s) immobilized. We strongly encourage you to use connective tissue support vitamins and/or cream. It is imperative that you take this as directed by the doctor; this will enhance the healing process. Ice can be applied to the area of injection for 15-20 minutes, 3-4 times a day, for the first 48 hours. Mild to moderate post-procedure pain can happen. Significant post procedure pain will typically resolve during the first few days after the procedure. If you are experiencing post procedure pain, you can take Tylenol as needed. If necessary, pain medication will be prescribed during your visit. If antibiotics are prescribed, please take them as directed. They will only be prescribed if they are needed. DO NOT TAKE anti-inflammatory medications such as; Advil, Motrin, Ibuprofen, Aleve, and Aspirin, for at least 2 weeks after your procedure. DO NOT TAKE blood thinners or any herbs, supplements or vitamins 3-4 days after your procedure. DO NOT TAKE systemic steroids such as; Prednisone, Hydrocortisone, etc. for at least 2 weeks following your procedure. Do not take hot baths or go to saunas during the first few days following your procedure. Avoid showering for 24 hours following your procedure. Do not consume alcoholic beverages for the first 7 days following your procedure. Avoid smoking. Smoking delays healing and can increase the risk of complications. Drink at least 64 ounces of water daily to help your heal properly. Water does not mean tea, coffee, soda or juice. Wound Care: Keep the area clean, apply a dash antibiotic ointment and a Band-Aid to the post-harvest site. If you see signs of: excessive redness, swelling or experience excessive pain, please call us at 248.876.4242.

3-7 Days Post Stem Cell Therapy: At this point you should gradually start increasing your daily activities and increase your exercise. To maximize the effects of the procedure, proper exercise is necessary. If you are still experiencing pain, continue you can take Tylenol as needed. If prescribed antibiotics please continue to take them as directed. They will only be prescribed if they are needed. Continue to use the connective tissue support vitamins and/or cream to enhance healing. Continue to avoid alcohol for at least 7 days after your procedure. DO NOT TAKE systemic steroids such as; Prednisone, Hydrocortisone, etc. for at least 2 weeks following your procedure. DO NOT TAKE anti-inflammatory medications such as; Advil, Motrin, Ibuprofen, Aleve, and Aspirin, for at least 2 weeks after your procedure.

7 Days Post Stem Cell Therapy: A follow up appointment must be schedule for 1 week (7 days) after your procedure. During the follow up the doctor will assess your healing and determine the next best course of action. If sutures were placed, this will be the time when they will be removed.

1-4 Weeks Post Stem Cell Therapy: Continue to use the connective tissue support vitamins and/or cream to enhance healing. At this point after your procedure, we highly recommend starting physical therapy to aid you in the healing process and help you regain full range of motion to the affected joint(s). DO NOT TAKE systemic steroids such as; Prednisone, Hydrocortisone, etc. for at least 2 weeks following your procedure. DO NOT TAKE anti-inflammatory medications such as; Advil, Motrin, Ibuprofen, Aleve, and Aspirin, for at least 2 weeks after your procedure.

If you have any questions, at any time after your procedure, you are welcome to call our office at 248-876-4242.

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Stem Cell Therapy – American Regenerative Clinic, Stem …

FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against … – Lexology (registration)

Stem Cell Clinic | Posted by admin
Sep 05 2017

The U.S. Food and Drug Administration (FDA or Agency) has become increasingly active in stem cell and regenerative medicine product regulation within the past year previously announcing that it would release a modified framework for the regulation of these products in September. On August 28, FDA issued two news releases about recent enforcement actions taken against Florida and California stem cell companies and clinics, as well as a statement from FDA Commissioner Dr. Scott Gottlieb. Dr. Gottlieb noted the promise of adult stem cells as viable therapies with the appropriate testing and scientific evidence, and vowed to work with industry. He also, however, stated that the Agency would increase its enforcement activities against unscrupulous actors in this field.

On August 24, FDA issued a warning letter to U.S. Stem Cell Clinic, LLC in Sunrise, Florida. for violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) namely, that the clinic (1) produced and administered unapproved stem cell treatments to patients; (2) violated current good manufacturing practices (cGMPs) and current good tissue practices (cGTPs); and (3) impeded FDAs inspection of the clinic. This same clinic was the subject of widespread stories in the popular press after publication of a New England Journal of Medicine article in March 2017 that reported varying degrees of vision loss in three patients who were treated with stem cells at the clinic. One day after FDAs news release about the warning letter, the clinic pushed back at the Agency by posting a public response and video.

On August 25, the U.S. Marshals Service seized non-commercial vials of live Vaccinia virus vaccine from StemImmune Inc. of San Diego, California. StemImmune allegedly used this vaccine, intended for very limited use against smallpox, to create an unapproved stem cell product by mixing the vaccine with stem cells and administering the product to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. The U.S. Department of Justice filed the seizure complaint and warrant on behalf of FDA in the U.S. District Court for the Central District of California (Southern Division).

These two recent events prompted Commissioner Gottlieb to issue a statement on August 28 about the future of regenerative medicine regulation at FDA. Dr. Gottlieb acknowledged the small number of unscrupulous actors that risk tarnishing the regenerative medicine field as a whole, as well as the sincere reports of the significant clinical potential of properly developed products. While promising additional details in the coming months, Dr. Gottlieb announced the following:

Although FDA has not yet released the full scope of its plans, companies, clinics and physicians currently developing or using stem cell products must recognize that the Agency is committed to taking enforcement actions when necessary to protect the public health. Therefore:

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FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against … – Lexology (registration)

Zika kills brain cancer cells, may find use as therapy – The San Diego Union-Tribune

Stem Cell Clinic | Posted by admin
Sep 05 2017

Zika, notorious for ravaging the brains of babies, could be useful in treating a particularly deadly brain cancer.

The virus kills glioblastoma stem cells, say researchers at UC San Diego and Washington University in St. Louis. They tested in human cell cultures and a mouse model of the disease

Moreover, Zika largely spared mature brain cells, the researchers say in a study published Tuesday in the Journal of Experimental Medicine.

People with glioblastoma rarely survive more than two years, although survival rates vary according to age and how aggressive the tumor is.

Study authors suggest a tamed version of the virus could be used along with other treatment to improve survival rates.

U.S. Senator John McCain was recently diagnosed with glioblastoma. The disease killed U.S. Senator Ted Kennedy, singer-actress Ethel Merman and retired baseball player Gary Carter.

Glioblastomas are treated with surgery, followed by radiation and chemotherapy. However, it is impossible to remove all the cancer without also removing healthy tissue and risking brain damage. So the cancer nearly always comes back.

Cancer stem cells cause the recurring tumors. These cells bear strong genetic resemblances to normal stem cells, and can proliferate greatly. Just one cell can regrow an entire tumor.

Glioblastoma stem cells also resist chemotherapy and radiation. But because they are stem cells, they are vulnerable to Zika. The virus causes an abnormally small head, or microcephaly, by destroying immature neural cells.

The study authors say a modified Zika virus could be applied after surgery, penetrating to the remaining cancer cells and killing them. One author, Jeremy Rich, M.D., is a renowned brain cancer specialist who recently joined UC San Diego from Cleveland Clinic. The first author, Zhe Zhu, also researches at UCSD.

Brain cancer specialists not involved with the study said by email it is scientifically sound, but there is a long way to go before it could be used in patients.

The science in this study is good considering the limitations of test tube and mice models, said Keith Black, M.D., chair of neurosurgery at Cedars-Sinai Medical Center in Los Angeles. What we don’t know is how these results will translate to humans, given how different the complex human tumors are compared to simplistic mice models.

Before a Zika-based therapy can be tested in people, toxicity studies need to be completed in animals, along with regulatory approvals from the U.S. Food and Drug Administration and the institutes where the trial is to be conducted, Black said.

The approach has precedent in viral therapy by San Diegos Tocagen to treat glioblastoma, said Faith Barnett, M.D., a neurosurgeon with Scripps Green Hospital in La Jolla. Tocagens therapy is already being tested on glioblastoma patients. It uses poliovirus and retroviruses, a class of virus that includes HIV.

Whether Zika virus is a better vector needs to be determined, Barnett said. Clearly, we need creative approaches to improve current cancer therapies.

Unlike Zika, Tocagens viruses dont directly attack the brain cancer cells. Instead, they deliver a gene to the cancer that primes it for destruction when exposed to a drug precursor or prodrug.

The prodrug is converted into a toxic drug inside the cancer cells through an enzyme the gene codes for. Normal cells dont get the gene, and so are unaffected by the prodrug.

Go online to for more information on Tocagens clinical trials.

For further reading

McCain completes round of radiation, chemo for brain cancer

UC San Diego hires renowned brain cancer expert Jeremy Rich

Blocking a tumor suppressor gene actually slows down one kind of glioblastoma

Survival time increases for those with deadly brain cancer: Study

Cancer genes hide outside chromosomes

Mom delays cancer care to protect baby she says saved her

Gary Carter to treat brain tumor with chemotherapy

Glioblastoma Anti-Angiogenesis Resistance Mechanism Found by Salk Researchers

(619) 293-1020

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Zika kills brain cancer cells, may find use as therapy – The San Diego Union-Tribune

US FDA steps up enforcement against unscrupulous stem cell firms –

Stem Cell Clinic | Posted by admin
Sep 03 2017

The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against “unscrupulous” stem cell firms.

Cell therapies are a new and emergent entity in the biopharma space, and last years 21st Century Cures Act looked to address industrys regulatory concerns by introducing the Regenerative Medicine Advanced Therapy (RMAT) designation offering personalised medicine makers anefficient development program for, and expedite review of, [their] drug if the drug qualifies as a regenerative advanced therapy.

But two separate enforcement actions in the past week have shown the abuse of such therapies within the US, and pushed the US Food and Drug Administration (FDA) to step up its regulation of the sector.

Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk, FDA commissioner Scott Gottlieb said.

As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.

Warning letter in Florida

US Stem Cell Clinic and its Chief Scientific Officer Kristin Comella received a warning letter for marketing its autologous stem cell products without FDA approval, as well as significantly deviating from current good manufacturing practice (cGMP) requirements in the manufacture of at least 256 lots.

The firm, located in Sunrise, Florida, claimed to offer stem cell treatments for a range of neurological, autoimmune, orthopaedic and degenerative diseases based on a patients own adipose tissue, which are processed into stromal vascular fraction (SVF) before being administered back into the patient.

However, the products are not the subject of an approved biologics license application (BLA) and have not demonstrated safety and efficacy. As such, the FDA said in a statement the company abused the trust of patients and put their health at risk and vowed to step up its vigilance against others offering unregulated stem cell treatment.

StemImmune and Smallpox

And yesterday the Agency announced it took action to stop the use of an unproven treatment developed by StemImmune Inc set to be administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

Under the FDAs orders, five vials containing 100 does of the non-commercially available Vaccinia Virus Vaccine (Live) were seized by the US Marshals Service. The vaccine was intended for combination with stromal vascular fraction to create an unapproved stem cell product intended to be directly injected into cancer patients tumours.

The Agency said it investigating how StemImmune sourced the vaccine, which is reserved only for people at high risk for smallpox and is not commercially available.

Gottlieb also attacked the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures.

He added:The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.

Furthermore, he pledged to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations.

Excerpt from:
US FDA steps up enforcement against unscrupulous stem cell firms –

FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against … – JD Supra (press release)

Stem Cell Clinic | Posted by admin
Sep 03 2017

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Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

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FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against … – JD Supra (press release)

Around the world – Bend Bulletin

Stem Cell Clinic | Posted by admin
Aug 29 2017


Travel ban in the courts In the latest arguments over President Donald Trumps travel ban, a three-judge panel of a federal appeals court in Seattle indicated Monday it would continue allowing grandparents and other relatives of U.S. residents to travel to the U.S. from six predominantly Muslim countries. But the judges were less forthcoming about their views on exceptions to a second part of the ban, suspending the nations refugee program. In July in a provisional ruling, the Supreme Court allowed exceptions to the ban for many relatives but not for most refugees. The Supreme Court will hear arguments in the case in October.

Stem cell clinic crackdown The Food and Drug Administration announced a crackdown on dangerous stem cell clinics Monday, while pledging to ease the path to approval for companies and doctors with legitimate treatments in the field. The agency reported actions against two large stem cell clinics and a biotech company, saying it was critical to shut down unscrupulous actors in regenerative medicine, which includes stem cell and gene therapies and immunotherapies. Stem cells can develop into many different types of cells, and are thought to have the potential to repair or replace damaged tissue. But the FDA has approved only a few stem-cell products.

Trump timed Arpaio pardon for storm ratings President Donald Trump offered a fiery defense Monday of his decision to pardon former Arizona Sheriff Joe Arpaio as Hurricane Harvey made landfall in Texas last week and claimed he timed it to attract maximum attention as television viewers were glued to storm coverage. Trump also suggested the Justice Department had political motives during the Obama administration for charging the former sheriff in a case concerning his illegal profiling of Hispanics. Actually, in the middle of a hurricane, even though it was a Friday evening, I assumed the ratings would be far higher than they were normally, Trump said.

European migrant influx Measures intended to stop migrants from trying to cross the Mediterranean were at the center of discussions in Paris among four European leaders who met with the leaders of three African countries Monday. The meeting, billed as a minisummit, brought together the leaders of France, Germany, Italy and Spain as well as Chad and Niger and one of Libyas leaders. Chad and Niger are transit countries for people fleeing war or poverty, while Libya is a departure point for crossing the Mediterranean and a center for traffickers who promise to get people to Europe.

Kenyas strict plastic bag ban Kenya will now punish with up to four years in jail anyone making, selling or importing plastic bags, putting in place one of the worlds toughest bans on the ubiquitous item that is blamed for clogging oceans and killing marine life. The rule, announced in March and put into effect Monday, also means garbage bags will be taken off supermarket shelves and visitors entering Kenya will be required to leave duty-free shopping bags at the airport. Kenya joins more than 40 other countries including China, the Netherlands and France that have introduced taxes on bags or limited their use.

German nurse suspect in 86 deaths A German nurse serving a life sentence for murdering two of his patients is believed to have killed at least 86 people entrusted to his care, officials said Monday, in what they described as an imagination-defying series of crimes. The nurse, identified as Niels Hoegel, was sentenced to life in February 2015, after a court found him guilty of administering overdoses of heart medication to some patients in an intensive care ward where he worked from 1999 to 2001. He was convicted of two counts of murder, two counts of attempted murder and causing bodily harm to patients and is serving his sentence. During his trial, the former nurse confessed to intentionally inducing cardiac crises in 90 of his patients, 30 of whom he said had died. That prompted officials to launch an investigation into the deaths of some 130 of Hoegels former patients. The results were presented Monday in Oldenburg. Authorities are waiting for the results of 41 toxicology reports, the results of which could drive the number of confirmed deaths even higher

Indian guru rape sentencing An Indian court sentenced a well-known guru to at least 10 years in prison for rape Monday, three days after followers angered by his conviction engaged in violent protests. Gurmeet Ram Rahim Singh was found guilty Friday of having raped two women more than a decade ago. Thousands of Singhs followers had gathered in the state where the verdict was announced. They responded by smashing cars, setting fire to buildings and attacking police officers, and the violence later spread to other cities in northern India. At least 38 people were killed, and more than 250 were injured.

Border dispute in Asia India and China agreed Monday to back away from their confrontation over a tiny slice of territory high in the Himalayas, easing tensions between the worlds two most populous countries. Both sides agreed to give some ground in order to end the standoff. In a short statement, the Indian government said it had reached an understanding with Beijing. China seemed willing to compromise but still claims the territory.


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Around the world – Bend Bulletin