A federal judge recently ruled in favor of a regenerative medicine clinic against the FDA
The FDA brought the lawsuit against Cell Surgical Network Clinic in 2018 in an attempt to assert regulatory authority over stem cell therapies. The agency argued that a physician’s use of his patient’s own stem cells as part of the medical treatment provided to the patient was equivalent to manufacturing a biological drug product and therefore subject to regulation by the FDA.
The court rejected this argument on Tuesday, ruling that the surgical procedure does not create a new prescription drug. The court wrote: “The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants’ SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells.”
This news opens up the possibilities and sets an important precedent for clinics in the United States to use autologous cellular treatments derived from adipose tissue, giving patients the right to use their own tissue to enhance regenerative processes and fight disease.
“We appreciate the Court’s clear and unequivocal ruling, which affirms what we have been saying for 12 years: that our innovative surgical approach to personal cell therapy is safe and legal,” said Dr. Elliott Lander, co-founder of CSCTC. “With this victory behind us, we look forward to refocusing our energy on our practice and leveraging life-changing stem cell treatments to support physicians and benefit patients across the country.”
As science advances, it’s inevitable that there will be more diverse forms of treatment with human stem cells. Whether the FDA gets on board and expands its rules about what is and is not legal is another question.
Unfortunately, much of what the FDA does falls into the category of politics. It’s usually unwise to make a decision about a particular kind of therapy or medical treatment based on whether it’s technically, currently legal.
It’s helpful to recall that many treatments that are fully legal began as experimental procedures that were not legally offered to the public but only took place in controlled research environments.
The good news is that stem cell therapy continues to make rapid advances on several different fronts, primarily those related to joint pain and associated discomfort. Athletes have made good use of the treatment and were, in fact, among the first major wave of clients for the technique when it was still brand new. After that, word spread about the effectiveness of stem cell treatment as more and more people turned to it as an alternative to surgery and prescription medication.
- Published in Press Releases
Global Stem Cells Group Subsidiary Adimarket to Launch Progenikine™ SVF Closed System
Global Stem Cells Group subsidiary Adimarket is preparing to launch Progenikine™, a new SVF closed system kit utilizing EmCyte technology, containing all the elements necessary to process adipose tissue and obtain stromal vascular fraction in a sterile environment.
MIAMI, May 31—Adimarket, a subsidiary of Global Stem Cells Group, Inc. is preparing to launch Progenikine™, its new and approved SVF closed system kit using EmCyte technology, and is expected to be available to physicians in July, 2016. The Progenikine kit contains all the elements necessary to process adipose tissue and obtain stromal vascular fraction (SVF) in a closed environment.
Adipose derived stem cells (ASCs) are used by physicians for a variety of indications. Most commonly, ASCs are isolated at the point of care from lipoaspirate (derived from liposuction) tissue as the stromal vascular fraction (SVF), harvested from the patient and immediately administered to the patient as an injection, or used to enrich fat grafts. Isolation of ASCs from adipose tissue is a relatively simple process performed routinely in cell biology laboratories, but isolation at the point of care for immediate clinical administration requires special methodology to prevent contamination, ensure integrity of the clinical procedure, and comply with 
regulatory requirements.
Developed in conjunction with Patrick Pennie, Emcyte CEO, and Maritza Novas Director of Research and Development for Global Stem Cells Group, Progenikine fuses elements from Emcyte systems with the Global Stem cells Group SVF protocols. The kit can provide a low cost, rapid and
simple alternative to traditional methods of isolating ASCs, particularly when smaller quantities are needed.
“We’re excited to launch the Progenikine kit, the newest product designed to help Global Stem Cells Group’s fulfill its m
ission to provide accessible products to our member clients,” says Benito Novas, CEO of Global Stem Cells Group. “These are the milestones that bring us closer to ensuring that more patients will be able to gain access to stem cell therapies.”
To learn more about the Progenikine kit, visit the Global Stem Cells Group website, email bnovas@stemcellsgroup.com, or call 305-560-5337.
About Global Stem Cells Group:
Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.
With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.
Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.
About Adimarket:
Adimarket, Inc., a division of the Global Stem Cells Group, is a cost-competitive online marketplace for quality regenerative medicine equipment and supplies for physicians and health care professionals.
Adimarket was founded to provide physicians and other health care professionals the tools they need to practice regenerative medicine in a medical office setting. Motivated by a firm belief in the impact the practice of stem cell medicine can have when dispensed in a doctor’s office, Adimarket provides physicians with the tools they need to provide patients with cutting edge treatments.
Adimarket’s experienced customer service representatives provide valuable guidance and advice regarding products relevant to individual practices.
About Emcyte:
Fort Myers, Florida-based EmCyte Corporation is a leader in autologous cellular biologics with the GenesisCS Component Concentrating Systems. These systems provide patients with the best opportunity for rapid recovery an
d provide practitioners with the most advanced clinical point of care experience. EmCyte systems are developed to meet every clinical requirement, giving the physician better clinical choices. EmCyte devices have been independently reviewed and show to produce buffycoat concentrations of 6x to greater than 10x baseline in 7mLs, with yields ranging from 70 percent to greater than 90 percent
EmCyte technology allows for the safe extraction of concentrated platelets and other regenerative cell types from the patient’s own blood. These cells are then re-suspended in a small volume of the patient’s blood plasma and then applied to the treatment site.
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- Published in Press Releases