Archive for the ‘Stem Cell Clinic’ Category

About Us – U.S. Stem Cell Clinic

Stem Cell Clinic | Posted by admin
Dec 19 2018

Dr. Comella is a world-renowned expert on regenerative medicine with a focus on adipose derived stem cells. She was named number 24 on Terrapins list of the Top 50 Global Stem Cell Influencers and number 1 on the Academy of Regenerative Practices list of Top 10 Stem Cell Innovators. Most recently, Dr. Comella made the list of Top 50 Functional and Integrative Medical Doctors/Scientists in the country by DrAxe.com, one of the most visited natural health websites in the world.

Dr. Comella has pioneered stem cell therapies from various sources including cord blood, bone marrow, muscle, and adipose. She led the team that gained the first ever FDA approval for a clinical trial using a combined cell and gene therapy product in the heart. In addition to advanced cell culturing experience, Dr. Comella has managed the development, manufacturing, and quality systems of a variety of cellular products. She has developed a wide range of regenerative techniques and products that have now been successfully implemented into the clinic setting. Her professional experience includes positions in several companies including US Stem Cell, VetBiologics, Tulane University and Osiris Therapeutics. Dr. Comella progressed from research engineer at Osiris Therapeutics developing stem cell therapies for osteoarthritis to building and managing the stem cell laboratory at Tulane Universitys Center for Gene Therapy. She was the co-founder and Chief Executive Officer of Stemlogix, a regenerative medicine company focusing on veterinary medicine.

She is currently serving as the Chief Scientific Officer and board member of US Stem Cell, a publicly traded company focusing on the discovery, development, and commercialization of autologous cell therapies for the treatment of degenerative diseases. She has been responsible for the development and implementation of cell therapies in the clinic for a variety of different indications for more than 7000 patients. Hundreds of practitioners world-wide have provided stem cell treatments to their patients using her protocols. Dr. Comella has a PhD in Stem Cell Biology and holds both an MS and BS in Chemical Engineering.

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About Us - U.S. Stem Cell Clinic

Brandon Stem Cell Clinic

Stem Cell Clinic | Posted by admin
Dec 19 2018

Umbilical cord cells are comprised of proteins, growth factors, and stem cells. Blood is collected from the umbilical cord and then purified to rid it from any factors that could cause your body to reject the treatment. One of our health care providers will inject the material from the treated cord blood into the damaged joint or joints. This allows the active compounds found in the cord cells to go to work instantly to begin to reduce inflammation and promote healthy cellular division and regeneration. 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 individual compound has a slightly different function, but combined, give your joints the needed material needed to kick-start healthy cellular renewal and regeneration of your tissue. The injection changes the chemistry inside the joint, creating a healthier environment that encourages positive, healing changes to take place. You will experience a better blood supply to the regenerative area, a reduction in damaging chronic inflammation, and stimulation of healthy tissue growth all because of this simple, non-surgical injection at our Brandon Stem Cell Clinic. Our goal in this process is to provide an alternative to invasive surgical procedures or drug intervention to manage or reduce pain. Surgical procedures occasionally result in infection, scar tissue, and even amputation in extreme cases. Prescription drug abuse is also reaching epidemic levels in Brandon and the rest of the country. At Brandon Stem Cell, we are looking to use umbilical stem cells to promote healing in the body in a holistic, minimally invasive approach.

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Brandon Stem Cell Clinic

Illinois Stem Cell Clinic – Illinois Stem Cell Clinic …

Stem Cell Clinic | Posted by admin
Oct 05 2018

Umbilical cord cells include stem cells, growth factors and a range of other beneficial proteins and compounds. We use blood from the umbilical cord 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 changes the chemistry inside the joint, creating a healthier environment that encourages positive, healing changes to take place. A better blood 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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Wisconsin Stem Cell Clinic

Stem Cell Clinic | Posted by admin
Sep 19 2018

Umbilical cord cells include stem cells, growth factors and a range of other beneficial proteins and compounds. We use blood from the umbilical cord 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 changes the chemistry inside the joint, creating a healthier environment that encourages positive, healing changes to take place. A better blood 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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Wisconsin Stem Cell Clinic

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: https://www.change.org/p/fda-don-t-shut-down-our-access-to-needed-stem-cell-therapy-treatment.

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.

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FDA Response - U.S. Stem Cell Clinic

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 ...

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

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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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)