Some Highlights by Walter P. Drake, Director
November, 2024
It all started when I went to Thailand in 2001 and began reading in the Bangkok Post of the amazing things going on with early stem cell therapies in Thailand. I never even knew what a “stem cell” was. By 2005 in Thailand, some Thai physician trained in the US was doing stem cell therapies on cardiac patients coming from the US. The patient’s own stem cells harvested from the blood, were sent to Israel for expansion (multiplication), and then injected back into the patient. As I reported previously, this was the observations by nurse/technician David Granovsky, from the USA, who was assisting with these therapies:
“In 2004 I worked for the first commercial stem cell treatment facility in the world. [VesCell Thailand]. I watched them as they treated congestive heart failure patients who were tired of being stuck on transplant lists for hearts that might never materialize. I watched these patients brought in on wheelchairs with gray complexions and oxygen canisters. I then saw them come back later on their own power with smiles on their faces and a bounce in their step. These were people who were doubling their ejection fractions (vol of blood pumped out of their hearts) and people who went from Level 3 or 4 congestive heart failure down to Level one. This is the difference between the rest of their short lives in a bed waiting for a heart transplant at Level 3 or 4 AND playing tennis, making love to their spouses, chasing their grandchildren around at Level 2.”
And so, with the backdrop of this exciting new medical therapy, I and some others formed the Panama College of Cell Science, not only for our own learning of a new field, but to serve as a repository for all manner of information, clinical studies, and protocols. And also to engage with others in grasping the essentials of an entirely new developing medical field: stem cell therapeutics.
Many of us figured that a lot more people have got to be educated to work in this new medical field, and there would be a need for many research assistants and lab personnel, clinical assistants, managers of clinics, biomedical engineers, developers of equipment and instrumentation for stem cell expansion and treatment, and so forth. Initially as now, the College followed the traditional historical format, in that, a group of scientists and educators having expertise and specialized knowledge in various fields, associate together as a faculty for the purpose of teaching. The Faculty of the College continues to determine the curriculum, pass on the adequacy of the students’ theses and independent work, and determines when the student has achieved mastery of the subject material such as to warrant the grant of a doctoral degree.
In 2011, the College (founded in the Republic of Panama) was privileged to receive a Certificate of Recognition from the California University Foreign Credential Evaluation Service (CUFCE) to the effect: “The Academic Board finds the Curriculum of the Panama College of Cell Science as equivalent to the curriculum of the regionally accredited and nationally accredited colleges and universities of the United States of America”. At that time CUFCE was on a list of foreign credential evaluators approved by the US Department of Education. The Department has since abandoned any list, instead referring students to “professional foreign credential reviewers”.
In 2013, for administrative efficiency and convenience, the College was folded into Blue Marble University as an autonomous college within the university, without any changes, retaining the 3-year online format.
During the last 10 years, the curriculum of the Panama College of Cell Science has been updated almost annually, many times twice per year as we strive to offer the very latest education and training in this amazing field. And what started out as a “biology” program in “stem cell biology” has evolved into the Panama College of Cell Science 3-year online PhD in Stem Cell Medicine.
Our students have seen the field evolve from taking a tube of patient’s blood and using adult stem cells after expansion to the international utilization of a patient’s “stomal vascular fraction” (SVF) collected via mini-liposuction. This latter procedure has become the go-to procedure in stem cell therapeutics because one can collect 400 times more stem cells from fatty abdominal tissue than from peripheral blood, thereby obviating the need for any cell expansion.
Although not permitted in the United States, causing some practitioners to set up overseas, we have seen positive and effective therapies being undertaken against our most serious conditions and diseases: most auto-immune diseases, muscular dystrophy, Parkinson’s disease, Alzheimer’s disease, cerebral palsy, liver diseases, multiple sclerosis, and scleroderma, to name a few. Nearly all such therapies are being performed overseas as the USA continues to be last to investigate, let alone adopt, such innovative therapies. The best centers are in Panama, Thailand, Mexico, China, and, at least prior to the war, Ukraine. It continues to seem to me that people in power do not want physicians successfully treating patients with their own stem cells, and thereby skipping pharmaceutical drugs. In America, it continues to seem like the health care industry wants to keep patients sick by offering a lot of expensive pharmaceuticals that in the end have no beneficial effect on our most serious diseases, and worse, exhibit side effects that might be fatal.
Our graduate students continue to advance the thinking in the field. The College is interested in ways to stimulate the patient’s own stem cells and thereby eliminate the need for any liposuction procedure. If stem cells could be activated by other means, then each patient’s own dormant stem cells could be awakened to achieve tissue repair or to suppress auto-immune diseases.
In this regard, platelet rich plasma (PRP) is being examined and studied as the “new” stem cell therapy. In PRP therapy, 100 ml blood is taken from a patient, processed to concentrate the platelets, then light activated to excite the platelets prior to re-injection into the patient. By using high dose, light activated PRP for intravenous injection, it is theorized that the patient will receive the very same stem cell stimulating growth factors, that are received in standard SVF stem cell therapy, thereby bypassing any need for abdominal liposuction.
Some excerpts from the Panama College of Cell Science 3 year online curriculum demonstrating our emphasis on stem cell therapeutics:
Course #642: PCCS Disease Treatment with Autologous Stem Cells – The course covers international treatments available using autologous stem cells (collected from the patient) including the very latest treatments for ALS. The primary international treatment centers are reviewed. The mechanism of action is studied. The purpose of the course is to bring to light the many curative techniques being used internationally, such as the repair of severed spinal cord using neural stem cells isolated from the patients nose. It is hoped that the student can gain insight to the fact that these current international treatments are no longer “hypothetical”, and hopefully will inspire the students to generate their own ideas for future work in their careers.
Course #644: PCCS 644: Fetal and Embryonic Stem Cell Treatment – A review of the techniques of using stem cells derived from human fetal tissue, and what diseases can be particularly controlled or cured. The course also includes a review of the current status of human embryonic stem cell treatments, why the international medical community has abandoned its interest in using embryonic stem cells, and also covering the two major drawbacks to embryonic stem cell therapy: Tendency toward proliferation (differentiation), making stem cells almost impossible to control once injected into another body, resulting in a differentiated cell ball of many types referred to as a teratoma; and the problem of cell rejection due to having “foreign” cell membrane antigenic determinants requiring a patient to take immune suppressing drugs.
Course #647: PCCS Growth Media, Growth Factors, and Paired Mice Experiment- This course presents a review of growth media for purposes of expansion of a patient’s collected stem cells, including with the use of autologous serum. The importance and identity of stem cell growth factors is presented in context to the very important paired-mice experiment. The course concludes with a discussion of exogenous growth stimulants such as Neupogen (filgrastim).
Course #649: Exosomes and the Rise of Birth Tissues. The biology, function, and biomedical applications of exosomes and extracellular vesicles are studied with emphasis on applications in stem cell therapy. This very important course expands on the findings of the “paired-mice” experiment to the effect that serum factors and not stem cells are the most important contributing element to achieving, boosting, and stimulating the body’s own natural repair mechanisms toward the control of our most debilitating diseases. And the most important source of exosomes are “birth tissues”: amniotic fluid, placental tissues, umbilical cord blood, and Wharton’s jelly.
Course #641: PCCS Mixed Cell Regenerative Medicine-We cover the new terminology for stem ell therapy, with emphasis on the 21st Century Cures Act: The Law Authorizing Adult Stem Cell Therapy in the United States. We review the many new developments in stem cell therapy taking place in the United States that really gained momentum beginning in 2016 including the use of and use of Platelet Rich Plasma and Stromal Vascular Fractions We look at the early history of stem cell therapy worldwide, juxtaposed to what was occurring in the US.
Course #670: PCCS Practical Lab– The Collection, Purification, and Use of the PRP and SVF Fractions. This is a laboratory course in which the student will learn step by step, through use of videos and other material, how the Platelet Rich Plasma (PRP) and Stromal Vascular Fraction (SVF) are collected from the patient’s blood or fatty tissue, concentrated through various centrifugation steps and enzymatic clean up, and final preparation for use in patients.
2016: As far as US law is concerned, the Court’s have gone back and forth on the question of whether a patient’s stem cells a “drug” under supervision of the Food and Drug Administration. In 2016, Congress passed legislation [21st Century Cures Act] essentially permitting stem cell therapy and requiring a consideration of patient testimonials and foreign-based therapeutic results.
The new law has been interpreted to permit new stem cell therapies if “preliminary clinical evidence of efficacy” can be shown. This is a very low bar to have to reach, made lower by the requirement that the FDA must consider “the submission of patient registries (another word for patient testimonials) or other sources of real-world evidence”, i.e. beneficial results of stem cell treatments overseas.
However, the law has been purposely ignored and no regulations were ever passed so as to implement the intent of the legislation.
2019: A federal court in Florida ruled that stem cell therapies must comply with the same FDA regulations as new drugs. This in my view is a nutty ruling…are you going to do a clinical trial to prove efficacy on each separate patient’s cells? How would such a test be designed?
2023: A federal court in California came to an opposite conclusion, finding that the use of a patient’s own cells in therapy is not the manufacture of drugs under FDA authority.
2024: The above finding was reversed on appeal, and we await any further appeal, if any.
All of this legal uncertainty has had a chilling effect on advancing this new therapy as many physicians are sitting on the sidelines, worried about making an investment in equipment and offices that might be lost. And the US government, as we saw with Covid, has no interest whatsoever in undertaking any clinical trials to determine the efficacy of stem cell therapy…most likely fearing a beneficial result which would upend all medical care as we know it.
But we here continue to study, learn about, and teach this amazing “new medicine”, and hope that one day, the amazing benefits of stem cell therapy with the patient’s adult stem cells will be available in my home country, the United States of America.
The Panama College of Cell Science continues to offer the only PhD degree in stem cell medicine in the world. The 3-year program is geared toward working adults and has students from many countries. Many US professionals and health care providers enroll in our program.
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