September 22, 2022
The Panama College of Cell Science offers the only online Ph.D. in Stem Cell Biology in the world. And we have been offering our stem cell doctoral program since 2005.
As hopes that embryonic stem cells could lead to cures evaporated over the years, stem cell therapies using adult stem cells grew rapidly worldwide to the point where, except in the USA, adult stem cell therapy is universally recognized as leading to cures and control of our most serious diseases. Students at the Panama College of Cell Science, especially those from the US, have been amazed to learn about autologous stem cell therapy and to read report after report of success in the medical literature.
At the Panama College of Cell Science, we have been teaching that autologous stem cell therapy using cells and messenger molecules harvested from belly fat in a mini-liposuction is the gold standard for therapy. This approach has been widely adopted worldwide. However, autologous stem cell therapy in the United States has been largely blocked, forcing patients to travel overseas to Mexico, Thailand, and Panama for this new and impressive “new medicine”.
Today we report on a federal court case that will change the trajectory of therapies in the US and open the door to the amazing control of many serious conditions…using the patient’s own stem cells!
The case is:
United States of America vs California Stem Cell Treatment Center Inc., et al.
Case #EDCV 18-1005 JGB
In the United States District Court for the Central District of California-Eastern Division
Honorable Jesus G. Bernal, United States District Judge
Decided August 30, 2022
In the most important case ever to be decided in the US concerning a physician’s right to administer autologous stem cell therapy, the US Federal Court ruled in favor of a stem cell clinic, wherein the stromal vascular fraction of stem cells obtained from a mini-liposuction are then separated from the fat cells, and re-injected into the same patient.
The US Food and Drug Administration (FDA) had sought to bar such treatments as being “drugs” and to enjoin the physicians from using the stem cell treatment.
The FDA lost. Stem cell therapy using the patient’s own cells is not the dispensing of drugs!
As the Court clearly and unequivocally stated in its conclusion of law:
“Defendants are engaged in the practice of medicine, not the manufacture of pharmaceuticals.”
Surprisingly, one would think that this case would be featured in major headlines. But except for some critical press in California, which has traditionally been opposed to stem cell therapy being used successfully world-wide (except in the US), there has been almost no publication concerning the importance of this case. Furthermore, we believe it very unlikely the FDA will take any appeal, since at the trial, the FDA presented little if any evidence to support their assertion that harvesting a patient’s stem cells for re-implantation into the same patient involves the use of a drug requiring FDA approval. Consequently, any Appeals court would be hard-pressed to find any facts supporting a contrary ruling.
One of the best summaries of the case was issued by the International Society for Stem Cell Application, and we repost their excellent summary August 2022 Here:
The FDA brought the lawsuit against [California Stem cell Treatment Center] 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.
And the actual case can be read in its entirety HERE:
Ruling And Judgment Stem Cell Therapy is Not a Drug Subject to FDA Regulation
The actual clinic involved in the law suit was the California Stem Cell Treatment Center, which operates two clinics in California:
The Beverly Hills Stem Cell Treatment Center:
The Rancho Mirage Stem Cell Treatment Center:
Both websites are largely the same and students in our online PH.D. program in Stem Cell Biology are encouraged to browse and fully study these websites. There you will find a listing of medical conditions currently being treated in the United States with autologous stem cell therapy including:
TRAUMATIC BRAIN INJURY AND CONCUSSION
NECK ARTHRITIS & SPINE DISEASE
BACK ARTHRITIS AND SPINE DISEASE
RHEUMATOID ARTHRITIS (AND RHEUMATOLOGICAL DISEASES)
CROHNS DISEASE AND ULCERATIVE COLITIS
CONGESTIVE HEART FAILURE (CHF)
POST MI MYOCARDIAL INFARCTION
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Quite an amazing list of diseases and conditions. The website also contains a nice diagram of their procedure:
At the Panama College of Cell Science, we go into great detail about what the SVF fraction is, and our students learn the procedure step by step including all kits necessary and useful to separating the stem cells from the fatty tissue liposate. We have probably the best online PhD program in stem cell biology ever designed. Our course, “Practical Lab”, is one of several courses training in the SVF protocol for collecting adult stem cells from fatty tissue aspirates.
As the physicians Mark Berman M.D. and Elliot Lander M.D. note on their website:
“Cell therapy around the world is shifting its focus from bone marrow based cells to adipose (fat) derived cells since the cells are easy to obtain and generally very robust. Adipose fat is an abundant and reliable source of stem cells. The best quality adipose cells are derived from the enzymatic digestion of liposuctioned fat which can be performed at the bedside in an essentially closed system to protect sterility. Autologous stem cells from a person’s own fat are easy to harvest safely under local anesthesia and are abundant in quantities up to 2500 times those seen in bone marrow.”
We can only applaud and thank these guys for presenting excellent evidence in the case so as to support only one result: That autologous stem cell therapy using the patients own stem cells is a medical procedure and that the patient’s own stem cells are not “drugs” requiring FDA approval!
And here is the secret to the success of these physicians against the FDA:
“If it would be a laboratory procedure, it would not be FDA compliant, but it’s not a laboratory procedure. We modified the technology to make it a surgical procedure instead of a laboratory procedure; we’re one of only groups in the world doing it this way. “
The Panama College of Cell Science
Online Ph.D. Program
in Stem Cell Biology