San Diego, CA, USA, July 18th, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to initiate its Phase II clinical trial for polyglutamine spinocerebellar ataxia (“PolyQ SCA”) to enroll patients at clinical sites in the United States. This is a key milestone for the Company’s international Stemchymal® SCA Phase II clinical trials program. [Read more…]
Stem Cell Treatments For COPD
A diagnosis of chronic obstructive pulmonary disease (COPD) can be alarming, but thanks to stem cell treatments for COPD, the situation may not be dire. Once a patient develops COPD, it means that he or she has developed complications to existing breathing problems. The chronic disease happens when inflammation in the lung interferes with airflow. Not being able to breathe properly and having frequent chest tightness can be distressing, especially when it is caused by a chronic disease, rather than a temporary illness like bronchitis. Thankfully, new options for treatment emerge every day. Among these options are stem cell treatments for COPD. [Read more…]
Should Stem Cells Be Regulated As Drugs?
Should stem cells be regulated by the U.S. Food and Drug Administration (FDA) as drugs? This is a complex question and one that the FDA has continued to refine over the past several years.
FDA Regulation of Stem Cells
In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER). [Read more…]
What Stem Cell Clinics Do You Trust?
Be in the know about leading stem cell centers you can trust in this article.
In this article:
- Negative News About Stem Cell Clinics
- FDA-Approved Stem Cell Centers
- Should You Believe the Hype About Stem Cell Clinics?
- Stem Cell Differentiation Capacity
- Therapeutic Promise of Stem Cells
- Legitimate Stem Cell Clinics
- Regulatory Oversight: What Are 351 and 361 Products?
- Clinical Trials for FDA Products
- Top Stem Cell Clinics
- Questions to Ask Before Undergoing a Stem Cell Therapy
The Leading Stem Cell Centers to Trust
Negative News About Stem Cell Clinics
Stem cell clinics have received a great deal of negative press, with prominent media outlets announcing that the Food and Drug Administration (FDA) had mailed “Warning Letters” to stem cell centers across the United States. According to a paper published in the journal Cell Stem Cell in June 2016, at least 351 businesses offer “unproven” stem cell interventions from clinics spread across the U.S.
Shortly after publication, the MIT Technology Review and Washington Post picked up the story, spreading the fear far and wide. Journalists then got enthralled with the story, calling it the “Wild West” of stem cells.
But, is this the whole story?
FDA-Approved Stem Cell Centers
What this hype does not cover is the promising medical potential of stem cell therapies, nor had it properly credited the legitimate stem cell clinics that comply with FDA regulations to offer effective medical treatments to populations of patients who otherwise have limited options.
Should You Believe the Hype About Stem Cell Clinics?
Today, the majority of medical clinics that offer stem cell treatments administer mesenchymal stem cells (MSCs), which they source from human fat (adipose tissue) or bone marrow.
Mesenchymal stem cells are a type of multipotent stem cell that is administered for a range of medical applications, including orthopedic repair, pain management, arthritis, and asthma.
When properly administered, multipotent self-derived stem cells (such as MSCs) can be safe for patient use.
Stem Cell Differentiation Capacity
It is important that the cells be multipotent (limited in their differentiation capacity), rather than totipotent (can become any cell) or pluripotent (can become most cells). There is also an additional level of safety that comes from having stem cells be self-derived, which doctors and scientists call “autologous.”
Stem cell differentiation capacity is explained below:
- Totipotent stem cells – Have the capacity to form an entire organism.
- Pluripotent stem cells – Can give rise to most, but not all, tissues within an organism.
- Multipotent stem cells – Undifferentiated cells that are limited to giving rise to specific populations of cells.
Therapeutic Promise of Stem Cells
While it is true that many stem cell centers are not properly regulated, the therapeutic promise of stem cells is also clear.
Today, nearly 30,000 scientific publications highlight research and therapeutic advances with mesenchymal stem cells (MSCs), and approximately 850+ clinical trials are investigating therapeutic uses of MSCs. Additionally, 300,000+ scientific publications about stem cells have been released.
Legitimate Stem Cell Clinics
This momentum is not surprising, because “We are not made of drugs, we are made of cells.”
However, the biggest issue with the hype surrounding stem cell centers is that it does not give proper credit to the companies that cooperate with regulatory bodies to ensure a safe and efficacious patient experience. Many of these companies also collaborate with offshore regulatory bodies to offer stem cell procedures approved by local regulatory agencies.
Regulatory Oversight: What Are 351 and 361 Products?
The FDA’s Center for Biologics Evaluation and Research (CBER) regulates human cell and tissue-based products in the U.S., known as “HCT/Ps.” The FDA has two different paths for cell therapies based on relative risk.
These pathways are commonly called “361” and “351” products.
The 361 products that meet all the criteria in 21 CFR 1271.10(a) are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called “361 products” because they are regulated under Section 361 of the Public Health Service (PHS) Act.
Clinical Trials for FDA Products
In contrast, if a cell therapy product does not meet all the criteria outlined in 21 CFR 1271.10(a), then it is “regulated as a drug, device, or a biological product under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act.”[1]
These “351” products require clinical trials to demonstrate safety and efficacy in a process that is nearly identical to that what is required for pharmaceutical products to enter the marketplace.
Stem cell centers must ensure that their treatments meet the FDA’s criteria to be classified as “351” products.
Top Stem Cell Clinics
Below, we cover six leading stem cell centers. Each one has treated large populations of patients with adult stem cells. At least one (Regenexx) is maintaining a Patient Registry to document long-term patient outcomes. Several of them, such as DVC Stem, have been treating patients for over a decade.
We are not advising patients to seek treatments from these companies. We are identifying them to allow readers to seek out more information.
1. Stem Cell Institute (Panama)
Founded by Dr. Neil Riordan, a globally recognized stem cell expert and visionary, the Stem Cell Institute in Panama is among the world’s leaders in stem cell research and therapy. Their treatments focus on well-targeted combinations of allogeneic umbilical cord stem cells, as well as autologous bone marrow stem cells.
The stem cells clinic uses stem cell therapies to treat various ailments, including the following:
- spinal cord injury (SCI)
- rheumatoid arthritis
- heart failure
- osteoarthritis
- multiple sclerosis
- autoimmune diseases
- genetic disorders, such as autism and cerebral palsy
Stem Cell Therapy for MS
One of their most recent studies exhibited the clinical feasibility of stem cell transplant process as a safe and effective treatment approach for patients with multiple sclerosis (MS).
Published in the Journal of Translational Medicine, the study showed that umbilical cord stem cells can slow down MS disease progression and decrease the frequency of flare-ups.
However, these stem cells did not exhibit the ability to repair damaged nerve cells or myelin sheaths.
Clinical Trials Results
After the completion of this clinical study, there was an improvement in MS patient disability. The 1-month mark of the study documented improvements in mobility, hand, bladder, bowel, and sexual functions. Importantly, the study demonstrated that a sustained one-year umbilical cord stem cell therapy has more durable benefits than current MS drug therapies.
2. Regenexx
Headquartered in Denver, CO, Regenexx offers self-derived (autologous transplant) same-day stem cell treatments to patients with orthopedic injuries and conditions. Regenexx clinics incorporate a variety of regenerative approaches, drawing patients from all over the U.S. who are seeking innovative, non-surgical treatments.
Regenexx Stem Cell Technology
The Regenexx® technology involves a procedure in which a small bone marrow sample is extracted through a needle and blood is drawn from a vein in the arm. These samples are then processed in a laboratory and the cells they contain are injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.
Beyond FDA-Approved Cell Therapy
Regenexx is also a licensed offshore clinic in the Cayman Islands where patients can undergo treatments that utilize laboratory-expanded (“ex vivo”) stem cell populations. This approach allows for a much larger number of stem cells to be administered to the patient than is supported by U.S. law, which currently prohibits laboratory procedures that the FDA considers to exceed “minimal manipulation.”
CEO and Regenexx Reviews
Dr. Christopher Centeno is the Founder and CEO of Regenexx. He is a global authority in the culture expansion and clinical use of adult stem cells to treat orthopedic injuries and the visionary behind the Regenexx® technology.
I am also a Regenexx patient. Click here to read my experience.
3. DVC Stem
Headquartered in Seven Mile Beach, Grand Cayman, physicians at DVC Stem have been using complimentary alternative therapies to clinically treat patients with various medical conditions. It is one of the most advanced stem cell clinics in the Caribbean, with IRB-approved protocols, a fully licensed staff, and a facility that is accredited by the medical governing bodies of the Cayman Islands.
DVC Partner Lab, Vitro Biopharma
DVC Stem sources its cells from its partner lab Vitro Biopharma Inc, a state of the art, US-based, FDA registered, cGMP compliant and ISO 9001 certified laboratory, and only use American Association of Tissue Bank (AATB) certified suppliers of full-term, ethically U.S.-donated human umbilical cords.
Led by Medical Director Louis A. Cona, MD, DVC Stem’s focus is on cord-tissue derived allogeneic stem cell therapy for degenerative conditions, wear and tear, and intelligent aging.
Notable Stem Cell Patients
Notable patients the company has treated include Lou Ferrigno (champion bodybuilder/actor), Michael Armand Hammer (businessman/philanthropist), and David Lyons (Founder, MS Fitness Challenge), and others .
4. Okyanos
Founded in 2011, Okyanos is a stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic degenerative conditions. Okyanos Cell Therapy uses internationally-approved technology to deliver a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) to patients with conditions such as the following:
- cardiovascular disease
- orthopedic issues
- neurological disorders
- urological indications
- autoimmune conditions
Stem Cell Treatment Centers
Okyanos maintains both a North American Office in Clearwater, FL, and a purpose-built Cell Therapy Surgical Center in Freeport, Grand Bahama. Okyanos’ stem cell treatments are performed in their state-of-the-art surgical centers under the care of board-certified doctors.
Okyanos is also fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. Click here to access our recent interview with Matthew Feshbach, Co-Founder and CEO of Okyanos.
5. GIOSTAR
The Global Institute of Stem Cell Therapy and Research (GIOSTAR) provides adult stem cells for autologous and allogeneic stem cell therapy, based on research by Dr. Anand Srivastava. This stem cell treatment group offers treatments for a range of chronic conditions, musculoskeletal injuries, and degenerative diseases.
Each of GIOSTAR’s clinics is licensed for the application of stem cell therapy. Since 2000, its team of scientists and clinicians have been developing and utilizing stem cell-based clinical protocols for the purpose of stem cell treatment.
Within the United States, GIOSTAR treats patients at its Chicago, IL, location. It also serves clients at its clinical sites based in Mexico, India, Brazil, Thailand and U.A.E.
In alignment with what we believe at BioInformant, GIOSTAR’s goal is to offer cutting-edge, extensively researched stem cell therapy options designed to improve a patient’s quality of life.
Click here to Schedule a Consultation or ask GIOSTAR a question about your medical condition.
6. Celltex
Celltex specializes in cryopreserving mesenchymal stem cells (MSCs) for therapeutic use. Celltex acquires stem cells by collecting a small fat sample from a patient, from which MSCs are extracted, isolated, multiplied, and stored for future use (known as cell banking).
Patients can then use their stored stem cells for regenerative purposes through infusions or injections performed by a licensed physician.
FDA-Approved Stem Cell Clinical Trials
Because the FDA considers an individual’s stem cells a drug if they have been expanded in large quantities, Celltex has begun the process of undertaking clinical trials on stem cells as a treatment for a range of medical conditions, seeking approval from the FDA to allow physicians to utilize these cells.
Approved Stem Cell Therapies in Mexico
Nonetheless, to meet the immediate needs of its clients, the company also has taken steps to meet the requirements of the FDA and COFEPRIS, a Mexican institution equivalent to FDA in MSCs import and export.
Celltex also works with Mexican hospitals that are established and certified that allowed the company’s cell-banking clients to receive their stem cells for medical purposes.
Questions to Ask Before Undergoing a Stem Cell Therapy
Although these leading stem cell centers have built a good reputation in regenerative medicine, it is still important to probe these clinics before the proper procedure. These questions should cover what to expect from the treatment, safety and emergencies, cost, and the patient’s rights.
Treatment
- What possible benefits can the patient get from stem cell therapy? How can these be measured and how long will it take?
- Are there other medications or special care the patient needs aside from the treatment?
- Which stem cell source best fits the patient’s condition?
- What are other treatment options for the patient’s condition?
- What is their stem cell procedure (from harvesting to follow-up check-up)?
Safety and Emergencies
- If the patient is given donor stem cells, what are the success and failure rates of the therapy?
- Are there possible long-term side effects of the treatment?
- In case a side effect develops, what do stem cell centers do, who will the patient reach out to, and how immediate can they respond to the side effect?
- How experienced are the doctor and the support staff who will perform the procedure?
- How advanced and sterilized is the clinic’s equipment?
Costs
- What are the expenses for stem cell therapy?
- What other costs will the patient incur?
Patient’s Rights
- What are the patient’s rights (confidentiality, update for new information, and the right to withdraw from the procedure)?
- What compensation will the patient be entitled to in case they will get injured while on the treatment process?
Understanding how these leading stem cell centers operate and what they do allows the patient to assess which of them is the right investment. While the information above is important to understand from a scientific and regulatory perspective, patient experiences are valuable too.
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Have you had a stem cell transplant? What stem cell clinic did you use? What treatment did you get and for what condition? Share your answers in the comments below.
Footnotes
[1] Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 1 Aug. 2017].
Future of Regenerative Medicine with Kyle Cetrulo of AuxoCell
I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
