UC-Davis Stem Cell Ethics Conference, Part 3

At the end of Part 2, the opening night of the conference had just ended. We pick up the next day with the main speakers. More secrets of illegal stem clinics are revealed…
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At the main conference the next day, I searched through tired-looking pastries on the side table, keeping a close eye on the other attendees. Virtually everyone seemed to be an academic. Paul Knoepfler was like an adorable teddy bear, huggable and self-effacing, all but blushing when I asked for a picture and an autograph.

There was the bouncy-ball-man again. He was leaning forward and talking loudly to a woman whose name tag proclaimed she was Alison Sorkin, a UC-Davis professor of bioscience. I tried to read his name tag, but he was turned away from me. He certainly did sound enthusiastic. A tall man leaned partly against a pillar, listening with a faint smile on his face, the corners of his eyes gently creased. I guessed his age at around sixty-five; he had the healthy, fit look of a man who had spent his life doing rigorous physical work. But his eyes were very sad. A woman stood listening to them all, a few feet away, her dark hair cut in a pixie shape around her soft face. Her hands nervously plucked at each other, and she seemed to be taking a series of short deep breaths, as if building a sentence that never quite got all the way to her lips. I wondered who all of them were. The identity of the woman mystified me just as much as the bouncy-ball man. I would be willing to bet that she wasn’t an academic either.

We all took our seats (and very uncomfortable ones they were, too,) and the presentations began.

Dr. Julie Freischlag, Vice Chancellor, Human Health Sciences and Dean, UC-Davis School of Medicine opened the program, and I have to say that I appreciated the way she related the day’s topics back to the patients. “I get calls and emails daily about the issue of stem cell treatments,” she said, sounding tired, although it was only nine in the morning. “As a patient, you turn into a different person, and people do get desperate. Can’t you do something? Should I try this? What have I got to lose if I do go to a stem cell clinic? These are the things I hear every day. But there are good reasons why we won’t do stem cell treatments in the U.S. unless they’re safe.”

HERE is where the artful, literary writing stops (and I don’t want to hear any comments from the peanut gallery, okay? 😉 We’re down to raw notes about the next few speakers. Quite honestly, this is why I postponed posting for so long. But this is some very important information, so don’t be afraid to dive in.

Lisa Ikemoto, JD, UC-Davis Law School

“Federal regulation of therapeutics in the US: Pros and Cons”

Clinical trial process

Leigh Turner, U of M “US clinics marketing unapproved stem cell interventions: ethical issues and regulatory concerns”

FDA officially does not take a position on FDA

They can’t make the decision on whether or not a patient gets a drug—it’s the drug company’s decision

The RTT laws are really just about making a statement

I thought I heard a snort from the bouncy-ball man at my side.

If you don’t want to read this entire thing, it boils down to this:

Dubious stem cell clinics in the U.S. don’t want to follow all the rules of the FDA in order to use their drugs and devices. StemGenex and Cell Surgical Network are the major, major offenders. In order to try to get around the FDA, they make up things. AKA, “Well, you didn’t SAY that shaving a monkey and then injecting the hairs into patients’ butts and charging them $50,000 a treatment was illegal!”

TRANSCRIBED SLIDES FROM TURNER’S LECTURE

SLIDE ONE:

Stem cell therapies for degenerative conditions

(note: anything in parentheses is a direct quote from the stem cell company’s website itself.)

“StemGenex takes a unique approach of compassion and empowerment while providing access to the latest stem cell therapies for degenerative neurological diseases including multiple sclerosis, Alzheimer’s disease, struck recovery and others. ”

“One of the leading stem cell companies in the U.S., StemGenex is currently providing access to cutting edge stem cell therapy for patients diagnosed with Parkinson’s disease and other degenerative neurological conditions.”

(link from company website on the bottom of the screen)

SLIDE TWO.

StemGenex makes many empirical claims about the stem cell therapies it advertises

“StemGenex is currently studying ways to more effectively deliver these adult stem cells directly to the areas of the body that need them most. One of those groundbreaking treatments is called intranasal stem cell administration.” Something about the noninvasive approach two cell therapy delivery.

This approach poses itself as a much safer and effective alternative to surgical brain transplantation of stem cells.

“Intranasal administration works by providing stem cells a pathway to travel through the nose to the brain, passing the blood-brain barrier.”

SLIDE THREE

StemGenex markets as treatments rather than cures.

“StemGenex is not offering stem cell therapy as a cure for any specific condition,disease, or injury.”

StemGenex’s web site makes repeated use of such phrases as “stem cell therapies.”

Rather, StemGenex claims it does not need FDA approval.

SLIDE FOUR.

Screen capture of cells surgical networks web site.

SLIDE FIVE.

Cell surgical network.

California’s CSN treatment center was established in 2010

In 2012 it expanded to become Cell Surgical Network.

It now reportedly has 51 stem cell clinics.

Cosmetic surgeons are the most common type of MD within the CSN.

CSN clients paid $8000 or more per procedure

SLIDE SIX

15 CSN clinics are based in California

A list

Bay Area stem cell treatment center

? Can’t read slide.

Irvine’s stem cell treatment center

Orange County regenerative medicine

San Diego stem cell treatment center

San Francisco State stem cell treatment center

Laguna Beach stem cell treatment center

Miracle Mile stem cell treatment center

National Institutes for Regenerative Medicine

Newport Beach’s stem cell treatment center

Silicon Valley’s stem cell treatment center

Southern California stem cell treatment Center

Laguna stem cell treatment center

Southern California stem cell treatment center

Visalia stem cell treatment center

SLIDE SEVEN

CSN clinics advertise stem cell therapies for over 30 diseases and injuries

ALS

Multiple sclerosis

Parkinson’s

Spinal cord injuries

Muscular dystrophy

Stroke

Peripheral neuropathy

Asthma

Post myocardial infarction

Congestive heart failure and cardiomyopathy

Lyme disease

Lupus

Relapsing at polyochondritis

Autoimmune hepatitis

Crohn’s disease

Rheumatoid arthritis

Myasthenia gravis

Hair restoration

Macular degeneration

Retinitis pigmentosa

Diabetic retinopathy

Peripheral neuropathy

Male incontinence

Erectile dysfunction

Knee, back, and neck arthritis

Spine disease

Hip, elbow, and shoulder problems

SLIDE EIGHT

Reported delivery modes

ID infusion

Subcutaneous injections

Directly into joints or organs

Nebulized

Into cerebral spinal fluid (can’t read a few words on slide) in catheter placed under the scalp

Into spinal fluid

SLIDE NINE

StemGenex and Cell surgical network regulatory concerns:

No record of peer-reviewed preclinical research

Medical Devices are not FDA approved for cell therapies

Clinics do not have the FDA premarketing approval for HCT T’s

Problematic institutional review board approval of patient funded studies

Failure to register with the FDA

SLIDE 10

Pubmed.gov and other sources contain no record of preclinical research published by StemGenex and Cell surgical network

I was unable to find any record of peer-reviewed clinical studies published by StemGenex and Cell surgical network

Are 53 U.S. clinics marketing stem cell therapies without first considering a preclinical research?

If so, how do their Physicians know what doses to administer, whether to administer SVF “soup” or purified MSC’s, if they will migrate following administration, whether there is a plausible basis for benefits vs risks, how risks should be described etc?

SLIDE 12

Incorrect practice of medicine claims.

“California stem cell treatment centers procedures fall under the category of Physicians practice of medicine, wherein the Physician and patients are free to consider their chosen course of treatment.”

“StemGenex and its affiliate treatment centers are offering treatments that are in the investigational stage to provide individual patients with stromal vascular fraction that contains their own autologous stem cells and growth factors. The treatment centers provide surgical procedures only and are not involved in the user manufacture of any investigational drugs.”

Medical Devices and HCT/Ps administered for therapeutic purposes fall under the scope of Federal regulation. This part is not in quotes.

Slide 13

(This slide has a diagram)

StemGenex’s ” stem-cell activating” medical device

StemGenex uses a “proprietary autologous adult adipose-derived stem cell treatment process developed over the last 10 years by AdiStem limited.”

This is the diagram.

At the top: fat stem cells for treatment

Harvest—separate—activate– treat

Picture of a person with a needle being stuck in their butt under “harvest.” “A small amount of fat 200 CC is taken from the waist area”

Picture of the needle going into some kind of circular thing and the stem cell coming out. “Stem cells are separated from fat cells.”

A picture of some kind of weird incubator thing. “The stem cells are activated with AdiLight 2.”

Picture of a person with an iv in their arm. “The activated stem cells are returned through the IV.”

Slide 14.

Empirical claims concerning stem genetics is “double activation protocol”

“The quality of your stem cell treatment hinges upon the fact that your cells are double activated. Our research indicates that other stem cell centers do not have the expertise to utilize double-activation.”

“Platelet-rich plasma contains numerous different growth factors, which are responsible for activating the adipose derived from cells. Each growth factor plays an important role in the body’s cells. Each growth factor plays an important role in the body’s wound healing and overall cell regeneration.”

“Laser activation further activates the stem cells by exposing them to a certain frequency/wavelength of light. This wavelength of light excites the cells, providing the highest level of activated stem cells possible.”

SLIDE FIFTEEN.

Adistem Medical device: Regulatory Concerns

The FDA website has no record of an Adistem medical device with Class III approval or 510K clearance

This medical device does not appear to have FDA pre-marketing approval for distribution in interstate commerce.

Clinicaltrials.gov lists one open-label Adistem study with no record of completion.

I was unable to find Adistem pre-clinical research, safety data, or efficacy data in peer-reviewed medical literature.

Before considering granting pre-marketing approval, the FDA would need to be provided safety and efficacy data related to “photo-activation” of stem cells, converting adipose-derived stem cells to neural cells, and achieving therapeutic outcomes.

SLIDE SIXTEEN

Medical devices used at CSN Clinics.,

SLIDE SEVENTEEN

Medikhan’s “Lipolist for aesthetic body contouring”

SLIDE EIGHTEEN’

More about the Medikhan thing

SLIDE NINETEEN

FDA classified adipose tissue cell processing devices as Class III medical devices requiring premarketing approval.

CSN claims the right to “off label” use of Medikhan devices. But this equipment is not FDA approved for any intended use involving enzymatic digestion of lipoproteins and isolation of adipose-derived meschenchymal stem cells.

This equipment appears to be subject to FDA pre-marketing approval process as Class III medical device.

CSN needs cleared investigational device (? Word) to conduct clinical trials and must then submit safety and efficacy data and apply to FDA for Premarketing Approval before introducing medical device into interstate commerce as “point of care” adipose derived stem cell processing equipment.

SLIDE TWENTY

“361 Products:” Autologous human cells, tissues, and cell and tissue based products that do not require pre-marketing approval

“21 CFR 1271.10(a)An NCT/P is regulated solely under section 361 of the PHS act and the regulations in this part if it meets all of the following criteria:

1.) “the HCT/P is minimally manipulated”

2.) the HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indication of the manfacturer’s objective intent

3.) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinicla safety concerns with respect to the HCT/P.”

SLIDE TWENTY-TWO

FDA’S interpretation of 21 CFR 1271: Processing Lipoaspirate into SVF Does Not Meet Minimal Manipulation Definition

• March 13,2012 warning letter to Steven Victor, CEO of Intellicell Biosciences

• April 20,2012 warning letter to Thomas Young, Owner and Medical Direction of Young Medical Spa

• September 24, 2012: warning letter to CEO and president of Celltex Therapeutics

• Example: “Your processing with (redacted) alters the original relevant characteristics for structured tissue such as adipose tissue as described in 21 CFR 1271.3(f)(1).” From warning letter to Celltex.

SLIDE TWENTY-TWO

“Minimal Manipulation” addressed in greater detail by three new HCT/P draft guidance documents

• October 2014: same surgical procedure exception under 21 CFR 1271.16(b): questions and answers regarding the scope of the exception; draft guidance for industry

• December 2014: minimal manipulation of human cells, tissues, and cellular and tissue-based products; draft guidance for industry and food and drug administration staff

• December 2014: human cells, tissues, and cellular and tissue-based products (HCT/Ps) from adipose tissue: regulatory considerations

SLIDE TWENTY-THREE

Homologous Use

(IMPOSSIBLE TO READ)

SLIDE TWENTY-FOUR

Stem Genex, Cell Surgical Network, and Homologous Use of HCT/Ps

 CSN and Stem Genex-affiliated clinics’ administration of adipose-derived “stem cells” to individuals with ALS,MS, Parkinson’s disease, spinal cord injuries, does not appear to meet 21 CFR 1272.3 © definition of homologous use.

 Warning letters to Intellicell Biosciences, Young Medical Spa, and Celltext Therapeutics all note that some of the adipose-derived “stem cell treatments” promoted and provided by these firms do not meet the definition of homologous use.

SLIDE TWENTY-SIX

“351 Products”:Bringing Biological Drugs into the U.S. Marketplace Via FDA Pre-marketing Approval Pathway

 U.S. federal regulations specify that autologous HCT/Ps not falling solely under Section 361 of PHS act “will be regulated as a drug, device, and/or biological product” and must emerge from a pre-marketing approval process that includes:

 Pre-clinical research

 Submission of IND or IDE applications prior to conducting human subjects research

 Testing safety and efficacy in clinical trials with “cleared” IND or IDE, IRB approval, and informed consent of research participants.

 Obtaining FDA approved Biologies License application, New Drug Application, or Premarket Approval Application.

SLIDE TWENTY-SEVEN

“Studies” with Institutional Review Board approval

 IRB’s for StemGenex and CSN have approved studies that appear to require FDA-cleared IND/IDE applications

 Either the IRB’S are unaware that StemGenex and CSN clinics charge clinical study participants for “stem cell therapies” or they are allowing these businesses to profit from charging subjects for access to unlicensed investigational agents

 I was unable to find public information about StemGenex’s IRB

 CSN’S IRB approved a 3000 person “patient-funded safety study” that included individuals with very different illnesses and few exclusion criteria.

 CSN solicits donations for the IRB that reportedly approved its clinical study.

SLIDE TWENTY-EIGHT

Registration of Facilities and Listing of HCT/Ps

 StemGenex and CSN are not listed on the FDA’s searchable registry of HCT/P facilities.

 There is no public record of these businesses providing the FDA with lists of the HCT/Ps they administer to patients.

 21 CFR 1271 describes requirements for registration and listing of HCT/Ps.

 53 clinics appear to be failing to comply with basic requirements of federal regulatory frameworks.

SLIDE TWENTY-NINE

CONCLUSION

 While StemGenex and CSN claim that they comply with federal regulations, there are many reasons to question such assertions.

 2 StemGenex-affiliated clinics and 51 CSN clinics are administering HCT/Ps and charging patients with ALS, MS, Parkinson’s disease, etc, without having FDA-cleared IND/IDE’S, conducting RCT’S, and submitting safety and efficacy data to the FDA before seeking premarketing approval.

 StemGenex and CSN blur important distinctions by charging for unapproved “stem cell treatment” and “therapies” administered in “studies” of questionable scientific, ethical, and regulatory standing.

 Federal and state regulatory bodies need to better regulate U.S. businesses selling unapproved and unproven stem cell interventions.

Whew! We made it through! That was a LOT of information, so yay for you for reading it. Skimming it. Whatever. 🙂

Cathy Danielson
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Cathy Danielson

In 2011, my life was shattered when I was diagnosed with a mysterious, incurable disease that always ends in blindness. The only hope on the horizon was a drug that broke all barriers in early testing. This drug, which replaces damaged cells in the eye, comes from the new class of stem cell based treatments that could cure the incurable, providing hope for patients with cancer, heart failure, ALS, cerebral palsy, and many more fatal and disabling diseases.

I survived the disease, and I now have the only remission on record. But a remission is not a cure. The stem cell drug I need for a real cure is now rapidly moving towards approval in the rest of the world, but in the USA, it—and all other cellular therapies-- are still stuck behind prejudice, ignorance, and lack of funding. Hundreds of millions of desperate patients with incurable diseases need these drugs.

That’s why I’ve gone on to fight for greater public education on stem cell drugs, knowing that our laws must be changed so that all of us can get access to the best treatments instead of our health and our lives being held hostage by special interests.

I’m now a patient advocate whose work on stem cells and patients’ rights has been published in outlets such as the Oregonian. I am a manager at popular science and financial blog www.stemcellinvestor.com and a frequent speaker at many venues across the spectrum, including churches, scientific conferences, and atheist groups, and everything in between. I’m also an advocate for Right to Try laws that would allow access to experimental medication for terminal patients at the state level. Read the entire story in my upcoming book, And the Blind Shall See: A Skeptic Patient Surprised by Faith, Science, Family, and Miracle Cures.
Cathy Danielson
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