January 25, 2013

Dr. Celia Witten, MD, PhD

Director, Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD, 20852

Re: California Stem Cell Treatment Center’s Marketing & Administration of Stem Cells to
Individuals with Multiple Sclerosis, Parkinson’s Disease, Muscular Dystrophy & Other Diseases

Dear Dr. Witten:

I am contacting you with regard to the California Stem Cell Treatment Center (CSCTC).1 I am
concerned about the many stem cell interventions marketed and apparently provided by this
organization. The California Stem Cell Treatment Center promotes stem cell “treatments” for multiple
sclerosis, Parkinson’s disease, muscular dystrophy, stroke, peripheral neuropathy, Chronic Obstructive
Pulmonary Disease, lupus, relapsing polychondritis, auto-immune hepatitis, Crohn’s disease,
rheumatoid arthritis, myasthenia gravis, lichen sclerosis, post myocardial infarction, cardiomyopathy,
lung disease, cardiac disease, neck arthritis and spine disease, back arthritis and spine disease, hair
restoration, interstitial cystitis, Peyronie’s disease, erectile dysfunction, male incontinence, and
problems of the knee, hip, elbow, hand, and shoulder.2 CSCTC claims that it provides stem cell
interventions as part of the practice of medicine. However, various assertions made by CSCTC suggest
that the stem cell interventions that it markets might require pre-marketing review and approval by the
FDA.

California Stem Cell Treatment Center, though its name suggests that it is based at a single location,
appears to operate on a “network” model. Two contact addresses in California are listed. These
facilities are Rancho Mirage Medical Center, situated at 72-780 Country Club Drive, Suite 301 in
Rancho Mirage, California, and Beverly Hills Medical Center, located at 120 Spalding Drive, Suite

1
California Stem Cell Treatment Center’s website is available at: http://www.stemcellrevolution.com
2
This list of diseases is available at: http://www.stemcellrevolution.com/currently-studying/
 2

300, Beverly Hills, California.3 CSCTC’s two founders, Dr. Elliott Lander and Dr. Mark Berman, work
at these locations.4 Over twenty additional doctors are based at other facilities located in Arizona,
Colorado, Florida, Indiana, Massachusetts, New York, North Carolina, and Canada.

CSCTC’s website, states, “Since 2010, we have been working with autologous (your own) adipose
derived stromal vascular fraction (SVF) providing investigational therapy to patients with various
inflammatory and/or degenerative conditions. Using technology developed in South Korea, we have
developed a closed surgical method to isolate this cellular medium (SVF) rich in stem cells. Under our
IRB (Institutional Review Board) approved protocol, we’ve been providing SVF deployment on an
investigational basis…. All affiliate members in the CSN [Cell Surgical Network] will contribute to our
IRB approved investigation.”5

Information provided by CSCTC is confusing because CSCTC’s website oscillates between describing
stem cell procedures as the “practice of medicine” and labeling them as “investigational research.” At
one point, CSCTC’s website states, “Is our procedure FDA-approved? No. However, California Stem
Cell Treatment Center’s procedures fall under the category of physician’s practice of medicine, wherein
the physician and patient are free to consider their chosen course of treatment. The FDA does have
guidelines about treatment and manipulation of a patient’s own tissues. At CSCTC we meet these
guidelines by providing same day treatment with the patient’s own cells that undergo very minimal
manipulation and are inserted during the same procedure.”6 Elsewhere, however, CSCTC states, “All
treatments are currently in the investigational stage. While we recognize our patients are seeking
improvement in their condition through stem cell therapy, each treatment is part of an ongoing
investigation to establish optimal parameters for treatment, to evaluate for effectiveness and for any
adverse effects. It is essential that patients understand they are participating in these investigational
(research) analyses. Once sufficient information is appropriately documented and statistically
significant, then data (validated by an Institutional Review Board) may be presented to the FDA for
consideration of making an actual claim.”7

CSCTC claims that it does not require pre-marketing approval to charge patients for the stem cell
interventions that it markets and provides. It states, “Our aim is to make cell based medicine available
to patients who are interested and to provide ongoing research data under approved Institutional Review
Board (IRB) validated studies…. At some point, once adequate amounts of data are accumulated, it
might be appropriate to submit the information to the FDA at which point an actual claim may be

3
Contact information for the California Stem Cell Treatment Center is available at:
http://www.stemcellrevolution.com/contact/
4
California Stem Cell Treatment Center’s founders are identified here:
http://www.stemcellrevolution.com/about-us/founders/
5
This information is available at: http://www.stemcellrevolution.com/about-us/founders/
6
This information is available at: http://www.stemcellrevolution.com/about-us/faqs/#6
7
This information is available at: http://www.stemcellrevolution.com/about-us/faqs/#7
 3

substantiated and recognized by the Agency. Still, these are your own cells and not ‘medicines’ for sale.
They are only being used in your own body. Most likely, no claims need to be made; rather a statistical
analysis of our findings would suffice to suggest whether treatments are truly and significantly
effective.”8

There are numerous reasons why patients and regulators should be concerned about various claims
made by CSCTC.

First, given that adipose-derived stem cells are marketed to individuals suffering from multiple
sclerosis, Parkinson’s disease, muscular dystrophy, stroke, and other illnesses, it appears that stem cells
are administered to patients in nonhomologous manner. If stem cells are provided to patients in
nonhomologous fashion, then it seems that CSCTC should have an Investigational New Drug
Application or Biologics License Application in effect. The FDA registry, “Human Cell, Tissues and
Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments”, does not list
California Stem Cell Treatment Center, Rancho Mirage Medical Center, or Beverly Hills Medical
Center. Searches indicate that the FDA website contains no information concerning New Drug
Applications (NDA), Biologics License Applications (BLA), or Investigational New Drug (IND)
Applications associated with the California Stem Cell Treatment Center or the Center’s affiliated
physicians.

Second, CSCTC claims that it engages in “minimal manipulation” of stem cells. It also states that it
isolates and implants stem cells on a “same day” basis. While CSCTC’s website provides little
information concerning how stem cells are processed prior to administering them to patients, for the
sake of promoting patient safety it is important to assess in an independent manner the extent to which
stem cells are or are not manipulated prior to injection or infusion. If stem cells are more than
minimally manipulated then presumably CSCTC requires pre-marketing approval from the FDA. If
stem cells administered by physicians affiliated with CSCTC are not more than minimally manipulated
then it is important to know what scientific justification exists for administering adipose-derived stem
cells for such a wide range of disease indications. It appears that this information is not provided on
CSCTC’s website or disclosed in other sources of information about CSCTC.

Third, while CSCTC indicates that stem cell investigational studies undergo review by an Institutional
Review Board, it does not disclose what IRB reviews these protocols, whether this IRB has appropriate
expertise to assess whatever studies CSCTC-affiliated physicians submit, whether it has any conflicts-
of-interests or other shortcomings, and whether before approving investigational studies the IRB
contacted the FDA and determined whether or not it was necessary for physicians to submit an
Investigational New Drug application before administering stem cells to paying patients.

Fourth, CSCTC does not explain why it is charging patients for stem cell interventions that it classifies
as “investigational” in nature and is apparently administering in the context of IRB-approved studies.

Fifth, CSCTC suggests that it might at some point submit data to the FDA. It does not state what
ethical, legal, and scientific basis it has for gathering data before submitting Investigational New Drug

8
This information is available at: http://www.stemcellrevolution.com/about-us/faqs/#22
 4

applications to the FDA for the many stem cell interventions that it markets. If CSCTC is considering
submitting safety and efficacy data to the FDA, presumably in order to obtain an approved biologics
license application, then it seems that it should have first submitted an Investigational New Drug
application and had appropriate justification for gathering safety and efficacy data.

Finally, I wish to draw to your attention the medical devices that CSCTC uses when “processing”
adipose-derived stem cells. According to CSCTC, “Using technology developed in South Korea, we
have developed a closed surgical method to isolate this cellular medium (SVF) rich in stem cells.”
CSCTC uses two medical devices manufactured by Medi-Khan, the Lipokit, and the Maxstem System,
as well as a cell counting system that is manufactured in South Korea and distributed by Invitrogen.9
The Lipokit and Maxstem System are the same Medi-Khan devices that I mentioned in my December
13, 2012 letter concerning Precision StemCell.

As noted in that earlier letter, Medi-Khan is located in Los Angeles. Medikan Korea Co. Ltd or
Medikan International, the manufacturer of these medical devices, is based in Pusan, South Korea. One
of the devices apparently used by CSCTC physicians is the Medi-Khan Lipokit. This device is
classified as Class II; it appears that in October 2008 Medi-Khan submitted to FDA 510(k) notification
of intent to market this device. According to the 510(k) summary, “The Lipokit is used in the tumescent
injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.”10 The summary also
states, “The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for
aesthetic body and facial contouring is desired.” There is no mention of stem cell procedures or stem
cell “processing” in information concerning device classification, use, or intended use.

The second medical device used by physicians belong to CSCTC’s network is the Medi-Khan
Maxstem. This device is listed on FDA website as a Class I device.11 The classification name is
“container, specimen mailer and storage, temperature controlled, non-sterile.” In photos the Maxstem
medical device resembles a mini-refrigerator.12 Its capacity to “process” stem cells is unclear. While the

9
This information is available at:
http://www.cacosmeticsurgery.org/index.php?src=gendocs&ref=conference_session_Berman_stem%20
cell&category=Conference
10
Medi-Khan (USA) Inc. (2008) 510(k) Summary (21 CFR 807.92(c)) October 23. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083455.pdf
11
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/LDetails.cfm?LID=312258
12
For example, see Medikan International’s website, http://www.medikanint.com/maxstem_detail.html
as well as the MaxStem listing on the website for EquipForSkin.
http://www.equipforskin.com/product/product_view.php?product_id=33. Please note that
EquipForSkin’s website lists the MaxStem medical device as a FDA-certified incubator. The
accompanying text states, “MaxStem is a specially designed, FDA registered incubator. Maxstem is a
specially designed medical incubator designed to effectively mix and culture the cell or tissue culturing
solution within the inner containers completely separated from the outside environment within a certain
temperature range.”
 5

FDA website lists this device, the information describing its intended use makes no reference to
processing and administration of autologous stem cells in clinical setting.

Whatever documents were provided to FDA concerning the Lipokit and Maxstem, Medikan, the South
Korean manufacturer of the Lipokit and Maxstem, appears to market these devices as a system capable
of functioning as an incubator, isolating adipose-derived stem cells using an “enzyme/collagenizer
solution”, and processing autologous stem cells in less than ninety minutes.13 It seems that a stem cell
“processing” system that is composed of two medical devices and used in administration of stem cells
to humans has entered the U.S. marketplace without having one of its primary uses brought to the
attention of the FDA.

Given the numerous questions and concerns prompted by the California Stem Cell Treatment Center’s
marketing and apparent administration of stem cells to patients, I wish to draw this organization to your
attention and urge you to determine whether it is compliant with federal regulations. Thank you for
considering this request. Please note that I am not writing on behalf of the institution of the University
of Minnesota. Rather, I am contacting you as an individual faculty member.

Yours sincerely,

Leigh Turner, PhD

Associate Professor
Center for Bioethics
University of Minnesota
N520 Boynton, 410 Church Street SE
Minneapolis, Minnesota, 55455
Phone: 612.626.4830
Email: turne462@umn.edu

cc: Lorrie Harrison McNeill, Director, Office of Communication, Outreach and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration

Richard D. McFarland, MD, Associate Director for Policy, Office of Cellular, Tissue and Gene
Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration

Theodore R. Stevens, MS, Associate Director for Information Management, Office of Cellular,
Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug
Administration

13
http://www.medikanint.com/maxstem_detail.html