Unproven products marketed as stem cell therapies could be risky, according to a new study from the Centers for Disease Control and Prevention, which analyzed bacterial infections from unapproved products derived from umbilical cord blood.
The case series study, published in JAMA Network Open, examined 20 bacterial infections in eight states. It involved reviewing medical records, sterility testing of products and whole-genome sequences of patient and product isolates for participants who developed bacterial infections after receiving stem cell treatments between August 2017 and September 2018.
The findings of this investigation show that stem cell therapies that are not FDA-approved or that are not used for the approved medical conditions can pose serious health risks to patients with no benefit, Kiran Mayi Perkins, MD, lead investigator with the CDCs Outbreak and Response Team, told Contagion. Currently, the only stem cell products derived from umbilical cord blood that are FDA-approved for use in the United States are approved for use in patients with disorders that affect the production of blood, but they are not approved for other uses. However, these products are often illegally marketed by clinics as being safe and effective for treating a wide range of diseases or conditions. Therefore, patients should be aware of the unproven benefits and the potential risks to their health when using unapproved and unproven stem cell products for conditions that they have not been shown to effectively treat.
All but one of the patients in the study required hospitalization after receiving stem cell treatment for conditions including osteoarthritis, rheumatoid arthritis and injury. The CDC performed sterility testing on vials of product and compared bacterial isolates with those from the patients.
We were surprised by the magnitude of bacterial contamination found in the vials that we tested; over half of the vials of the stem cell product that we tested were contaminated with bacteria, and many of these vials had very high bacterial counts, Perkins said.
Unapproved stem cell products have been marketed for conditions such as joint diseases, sports injuries and chronic pain and have become more prevalent as people seek products to prevent and treat COVID-19, the study noted. However, these uses are not approved by the US Food and Drug Administration (FDA).
ReGen Series products processed by Genetech and distributed by Liveyon were recalled after bacterial infections were reported in Texas and Florida in 2018, and a national investigation was launched. Information was gathered about patients, product administration, infection control practices and product manufacturing and distribution.
The bottom line is that many stem cell clinics are offering unproven products that have the potential to be dangerous, Perkins said. There is good research that is being done on stem cell therapies, but there are also a lot of clinics that are selling stem cells for unproven uses. To date, the only stem cell treatments approved by the FDA are products made from a donors umbilical cord blood that are used to treat certain cancers and disorders of the blood and immune system. If the cells are being used to treat other conditions such as pain, orthopedic conditions, autism, anti-aging, or COVID-19, they are not approved and may not be safe. We urge all patients and health care practitioners considering stem cell therapies to ensure that the stem cell product is being used for the approved indication or under an Investigational New Drug Application (IND) and is on FDAs list of approved products.
The states in which confirmed bacterial infections were identified as of March 2021 are Texas, Florida, California, Arizona, Kansas, Maine, Colorado and Massachusetts.
The treatments were injected into the patients knees, shoulders, spine or digits or administered through intravenous infusion or as a nasal spray. Infections included 10 at the injection site, five bloodstream infections and five with both injection site and bloodstream infections. Most common bacteria were Escherichia coli and Enterobacter cloacae.
CDC will continue to investigate any reports that it receives that are concerning for infectious risks to patients associated with the receipt of stem cell products and will report these to FDA, the agency that has regulatory oversight for these types of therapies, Perkins said.
- NIH researchers develop first stem cell model of albinism to study related eye conditions - National Institutes of Health - January 16th, 2022
- Exploring the relationship between stem cells and COVID-19 - News-Medical.Net - January 16th, 2022
- Trial of Cell Therapy to Raise HbF Levels Showing Potential, But... - Sickle Cell Anemia News - January 16th, 2022
- Nowakowski Considers CD19 Therapy in Transplant-Ineligible DLBCL - Targeted Oncology - January 16th, 2022
- More info needed to recommend nonembryo stem cell treatments - Oil City Derrick - January 16th, 2022
- Impact of Cancer Stem Cells and Cancer Stem Cell-Driven Drug Resiliency in Lung Tumor: Options in Sight - Newswise - January 16th, 2022
- Clonal evolution in patients developing therapy-related myeloid neoplasms following autologous stem cell transplantation - DocWire News - January 16th, 2022
- Severe Combined Immunodeficiency Treatment Market: Availability of Drugs and Immune-related Treatments Are Anticipated to Drive the Global Market -... - January 16th, 2022
- Cell and Gene Therapy Business Outlook Service - Yahoo Finance - January 16th, 2022
- 5 questions facing gene therapy in 2022 - BioPharma Dive - January 16th, 2022
- Bayer Strikes "Mammoth" CRISPR Deal to Bolster Cell and Gene Therapy - BioSpace - January 16th, 2022
- Outsmarting Cancer: Next Generation Therapies - BioSpace - January 16th, 2022
- The Fusion of mRNA and Immunotherapy - NEO.LIFE - January 16th, 2022
- Pain In The Shoulder? Reasons Why You Shouldn't Shrug It Off - TheHealthSite - January 16th, 2022
- ASU Biodesign Institute receives $5.2M from Michael J. Fox Foundation to advance fight against Parkinson's - Arizona State University - January 16th, 2022
- I Am Very Lucky That These Days Are Not Painful for Me, Says MS Fighter Selma Blair as She Shares an Update Amid IVIG Treatment; Making Time for... - January 16th, 2022
- Popular Erie bowler, recovering from leukemia, excited to compete in Times-News Open - GoErie.com - January 16th, 2022
- They wanted to cure heart disease. They discovered a way to grow a different kind of muscle - Haaretz - January 16th, 2022
- Christina Applegate says it's 'sad' she and 'The Sweetest Thing' co-star Selma Blair both have MS - Yahoo News - January 16th, 2022
- Private cord blood bank CellSave Arabia receives the first DHA license to operate as a Cord Blood and Stem Cell Center - Gulf News - January 16th, 2022
- Therapeutic Solutions International Successfully Treats No Option Patients with its JadiCell Stem Cell Therapy While Advancing Preparations for Phase... - January 2nd, 2022
- Exclusive: Ronnie Coleman on Recent Weight Gain, Current Strength, and Health Progress - BarBend - January 2nd, 2022
- Mesenchymal stem/stromal cell-based therapies for severe viral pneumonia: therapeutic potential and challenges - DocWire News - January 2nd, 2022
- Brainstorm Cell Therapeutics (BCLI) Receives FDA Authorization for Expanded Dosing Program; Shares Higher - InvestorsObserver - January 2nd, 2022
- Cell Freezing Media for Cell Therapy Market Size 2021 Analysis by Top Companies | Biolife Solutions,Thermo Fisher Scientific,Merck,Ge Healthcare ... - January 2nd, 2022
- Stem Cell Treatment Improves Type 1 Diabetes in 1 Patient - Everyday Health - December 23rd, 2021
- Avra, Inc. Completes its Merger with Springs Rejuvenation, LLC, a Stem Cell and Anti-Aging Treatment Company - GlobeNewswire - December 23rd, 2021
- Global Regenerative Medicine Market is Expected to Reach USD 57.08 Billion by 2027, Growing at a CAGR of 11.27% Over the Forecast Period. -... - December 23rd, 2021
- Importance of stem cells-Past, present and future - Express Healthcare - December 23rd, 2021
- Stem cell therapy holds immense promise for the treatment of patients with non-healing ischemic leg wounds - Ibcworldnews - December 23rd, 2021
- BioRestorative Therapies, Inc. Releases Year-End Message - BioSpace - December 23rd, 2021
- Corneal epithelial differentiation of human pluripotent stem cells generates ABCB5+ and Np63+ cells with limbal cell characteristics and high wound... - December 23rd, 2021
- Receiving CAR-T therapy sooner improves lymphoma survival, according to study published in New England Journal of Medicine - Newswise - December 23rd, 2021
- Cell Therapy Market becoming larger and Massively Growing up with CAGR of 25.6% mainlander.nz - mainlander.nz - December 23rd, 2021
- City of Hope presents leading-edge research on blood cancer therapies and its vaccine to reduce stem cell transplant complications at American Society... - December 23rd, 2021
- This Startup Is Makingand ProgrammingHuman Cells - WIRED - December 23rd, 2021
- Daiichi Sankyo Authorizes the First YESCARTA (Axicabtagene Ciloleucel) CAR T-cell Therapy Treatment Site in Japan - Business Wire - December 23rd, 2021
- Communication between cells plays a major role in deciding their fate > News > USC Dornsife - USC Dornsife College of Letters, Arts and Sciences - December 23rd, 2021
- Emendo Biotherapeutics and Seattle Childrens Research Institute Announce Collaboration to Develop CRISPR-based Therapeutic Strategy for Severe... - December 23rd, 2021
- National Advertising Division Recommends Cryo-Cell Discontinue or Modify Certain Health-Related Claims for Cord Blood Banking and Treatment Services -... - December 23rd, 2021
- Systemic Mastocytosis Treatments Gain Hope Due To Increasing Novel Treatment Options - PRNewswire - December 23rd, 2021
- Seven tech trends to watch in 2022 | The Star - Toronto Star - December 23rd, 2021
- Seven tech trends to watch in 2022 | ThePeterboroughExaminer.com - ThePeterboroughExaminer.com - December 23rd, 2021
- Stem Cell Therapy: Alternative Treatment to Hip & Knee ... - November 22nd, 2021
- How The Overlap Between Artificial Intelligence And Stem Cell Research Is Producing Exciting Results - Forbes - November 22nd, 2021
- Selma Blair Posts Nude Diving Photo After MS Stem Cell ... - November 22nd, 2021
- Stem Cell Therapy Reduces Need for Nearly 10% of Hip Replacements - Yale School of Medicine - November 22nd, 2021
- Stem cell therapy for heart failure lowers risk of adverse outcomes - Cardiovascular Business - November 22nd, 2021
- A second HIV patient may have been 'cured' of infection without stem cell treatment, in extremely rare case - CNN - November 22nd, 2021
- The Promise of Stem Cells to Help Children with Autism - Entrepreneur - November 22nd, 2021
- Global Cell Therapy Manufacturing Market Competition Forecast & Opportunities to 2026 - ResearchAndMarkets.com - Galveston County Daily News - November 22nd, 2021
- Dr Pengyi Yang wins National Stem Cell Foundation Metcalf Prize - News - The University of Sydney - November 22nd, 2021
- BioRestorative Therapies Enters into Letter of Intent with PRC Clinical - BioSpace - November 22nd, 2021
- SC21- 21st century cellular medicines specialists - The Thaiger - November 22nd, 2021
- From asthma to cancer to infertility, the new treatments, jabs and meds making us healthier... - The Sun - November 22nd, 2021
- New hope for bowel cancer patients as fresh partnership between Carina Biotech and CellVec enables advancement of clinical trials. - Bio-IT World - November 22nd, 2021
- FDA Approves Merck's KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - Business... - November 22nd, 2021
- Mum with brain fog and pins and needles in hands devastated by 'ticking time bomb' MS - Mirror.co.uk - November 22nd, 2021
- CAR T-cell therapy: Hear from a Canadian patient - CTV News - November 8th, 2021
- Talaris therapy ends need for immune drugs in transplant patients - - pharmaphorum - November 8th, 2021
- Treatment Sequencing Could Change With Complementary Combinations and CAR T Options in B-ALL - OncLive - November 8th, 2021
- Parkinson's gene therapy restores responses to dopamine-boosting drug in mouse models - FierceBiotech - November 8th, 2021
- Studies: CAR-T therapies superior to standard treatment in blood cancer - STAT - November 8th, 2021
- Salit Discusses the Use of Staging and Grading for Patients With GVHD to Choose Appropriate Treatment - Targeted Oncology - November 8th, 2021
- Orchard Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Business Updates - BioSpace - November 8th, 2021
- Global Stem Cell Therapy Market Size, Analytical Overview, Growth Factors, Demand, Trends and Forecast to 2026 - Northwest Diamond Notes - November 8th, 2021
- BioLineRx Announces an Oral Presentation and Three Poster Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting &... - November 8th, 2021
- CRISPR Therapeutics Provides Business Update and Reports Third Quarter 2021 Financial Results - Yahoo Finance - November 8th, 2021
- Team finds way to enhance stem cell therapy for CNS injuries - BioPharma-Reporter.com - October 28th, 2021
- Stem cell therapy can help combat common symptoms of aging - The Mountaineer - October 28th, 2021
- Stem Cells Used to Treat Avascular Necrosis of the Femoral Head - Yale School of Medicine - October 28th, 2021
- Vitti Labs Announces FDA Approval of IND Application for Phase II Clinical Trial of Combination Mesenchymal Stem Cell and Exosome Treatment of Novel... - October 28th, 2021
- Biohaven Enrolls Phase 1a/1b Clinical Trial of BHV-1100, Lead Asset from its ARM (Antibody Recruiting Molecule) Platform, in Combination with NK Cell... - October 28th, 2021
- The Power of the Immune System: New Treatment for Painful Blood Cancer Side Effect - Curetoday.com - October 28th, 2021
- Global Cell Therapy Market Research Report 2021: Opportunities with the Approval of Kymriah and Yescarta Across Various Countries -... - October 28th, 2021
- Pursuing Optimal Therapy Remains a Challenge in Indolent B-Cell Lymphoma - Targeted Oncology - October 28th, 2021
- Stem Cell Therapy Market Research Report by Cell Source, by Type, by Therapeutic Application, by End-User, by Region - Global Forecast to 2026 -... - October 16th, 2021
- Harvard's R&D alliance with Resilience to advance manufacture of complex medicines - Harvard Gazette - October 16th, 2021
- A New Line of Defense in Blood Cancer: Natural Killer Cell Therapy - Curetoday.com - October 16th, 2021
- Dr. Kahl on the Potential Utility of Frontline CAR T-Cell Therapy in MCL - OncLive - October 16th, 2021