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The following article and correspondence relate to the clinical trials of encapsulated islet transplantation announced recently by Dr. Patrick Soon-Shiong of VivoRx in Los Angeles. While we all hope for a successful outcome, the information is provided without endorsement or verification by this foundation. Readers are encouraged to seek independent validation.

Here we are a few weeks after posting this information. Before forming an opinion of this whole episode in diabetes history, be sure to read the June 30, 1998 news story on Mylan and Dr. Soon-Shiong.

My Own Injection

Can Dr. Soon-Shiong Perform Miracles? 
A New Trial for 24 Islet Cell Transplant Recipients


I recently attended a diabetes conference called "A Day of Hope" in Palm Springs, Calif. The featured speaker was islet cell transplant researcher Patrick Soon-Shiong, MD. He made a surprising announcement there -- but first a little background. 

Because our magazine has followed his work for five years, I can fill you in on some of the history that wasn't included in his talk. Soon-Shiong performed the first whole pancreas transplant in 1987 at UCLA. Because he found this cumbersome, he started working on transplanting just the insulin producing islets. He has cured diabetic dogs with transplanted islets at UC Davis. 

He has found success using a special seaweed to encapsulate the islets so the body won't reject them. (The dog research was published in the Proceedings of the National Academy of Sciences in June 1993.) 

 Also speaking at the conference was Soon-Shiong's first human islet transplant recipient Steven Craig. Diabetes Interview first interviewed Steven about his transplant in 1993. Steven is taking anti-rejection drugs because of his transplanted kidney, and until now, only kidney transplant patients were eligible to receive islet transplants. Steven received his first batch of islets in May of 1993, then a booster in November of '93 and then another booster of islets in March of '96. His A1c has averaged 7.2% and his C-peptide is 1.2. Now he only needs to take insulin occasionally. 

Soon-Shiong has performed transplants on two patients in this country. So far, Steven Craig's has been the most successful. I inquired about the second islet transplant patient, Clarissa Hooper, and was told she was not doing well. She recently needed to have a leg amputated. 

In 1994, Soon-Shiong told me that he had FDA permission to perform transplants in 19 more recipients, all immunosuppressed kidney transplant patients. This never happened, however. At one point, I was told by Soon-Shiong that the pancreases from human cadavers which he needed to proceed in his work were being diverted to other competitive researchers, stalling his work. 

 Undaunted, he switched to using pig islets and started to develop a method to clone the human islet. 

 This was the research he discussed at "The Day of Hope" meeting. He announced his successful transplant of pig islets into a diabetic man which took place in New Zealand, where transplants are not as restricted as in this country. The patient there received encapsulated pig islets, without immunosuppression, and is now only taking 20 percent of his usual dose. Patrick wants to duplicate this success in this country. 

His big announcement in Palm Springs was that: he now has FDA approval to transplant islets into 24 more people, without using immunosuppression. This will be the first time in the United States that this procedure will be tried on non kidney transplant patients. 

 Some of these 24 will get pig islets and some will receive human islets. He gave a phone number for anyone interested in the trial. (Call Margaret at (760) 773-1403 to get an application.) 

 The only requirements are that you must be over 18 and have an A1c of 9.5% or greater. I found this news disturbing because the conference promoters had arranged for about 70 children to meet with Steven Craig privately to give them "hope." I worry that the older kids might give up on the hard work of controlling blood sugars so they can qualify for the trial. 

 In December of 1997, Soon-Shiong spoke in Washington, D.C., to an audience of his peers. He had a special announcement there also -- he found a way to compel a human islet to proliferate 32 times, claiming that the islets were fully responsive. They were not impressed. 

I am told that the reaction of the audience (all professionals in the same field) was overwhelmingly negative with a lot skepticism. Apparently this is because he did not back up his claims and answered questions by saying the information was proprietary. Members of the audience countered that answering at least some of the questions would not have divulged any proprietary information. 

 Considering the audience, this response might just be professional jealousy. The room was mostly stocked with the old boys network of researchers. The rejection of Soon-Shiong by this group would not be surprising. If he is right, then everybody else's work in the field is finished and their careers are over. 

So where does that leave us? What should we believe? 

 As a journalist, in 1993 I received a press package with a photograph of Soon-Shiong's beaker of islets pouring into Steven's abdominal cavity several days before the first transplant ever occurred. This came with a slick press release and an 800 number people could call to volunteer for a transplant. Soon-Shiong has been collecting names of diabetics ever since, so I know he won't have any difficulty getting 24 new patients. Don't be discouraged if you don't get in. I have to tell you though -- I wouldn't do it. It's an experiment, and it could be dangerous. 

 A recent study points to possible "sleeping viruses" living in pig tissue which could infect man after a transplant. Though it would be rare to catch something from a pig, it is theoretically possible. For example, some believe the AIDS virus may have come from a monkey. 

After hearing Dr. Soon-Shiong's glowing report of his work, some in the audience in Palm Springs wondered if it was a giant hoax. However, if Soon-Shiong is right, it could be a real cure for diabetes. 


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Board of Trustees
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Marcia Caden
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Joel Shapiro, M.D.
Patrick Soon-Shiong, M.D
April 27, 1998 


We are pleased to announce approval from the FDA to begin clinical trials on diabetic patients who are non-immunosuppressed. The need of all diabetics has been foremost in our minds and we thank you for all your interest and support throughout the past years. 

Enclosed please find an Inclusion/Exclusion Checklist.  If you are interested in participating in the trial, please fill out the checklist and return by mail in the enclosed self addressed envelope. 


Patrick Soon-Shiong, M.D.

Phase I/II Prospective Study of the Safety and Efficacy of Encapsulated Freshly Isolated and Cultured Human Pancreatic Islet Transplantation in Patients with Type 1 (Insulin- Dependent) Diabetes Mellitus 
Inclusion/Exclusion Checklist

Patient Name:  
Phone Number: 
Date of Birth:

Inclusion Criteria: Response to all items must be a "YES" for a patient to qualify


Insulin-dependent diabetes mellitus as evidenced by: 
Glucagon-stimulated C-peptide <0.1 ng/mL 
Insulin dependence for >5 years 
Medical history consistent with insulin-dependent diabetes mellitus 
Hemoglobin A1c (HbA1c) > 9.0% 
Age 18-50 years 

Type 1 diabetic patient without end-stage nephropathy and with labile diabetes as evidenced by at least 12 hypoglycemic episodes (blood glucose levels < 60 mg/dL) during the preceding year. 

Sufficient cardiac reserve: stress exercise treadmill tolerance test demonstrating absence of severe coronary heart disease. 

Males or females are eligible, but females must not be pregnant as evidenced by a recent negative urine or blood pregnancy test (or by proof of sterility) and adherence to acceptable birth control procedures. 

A thorough understanding of the risks and benefits of the transplantation procedure. 

Exclusion Criteria: Response to all items must be "NO" for a patient to qualify 

Advanced nephropathy as evidenced by creatinine clearance > 70 ml/min 

Failure of stress exercise treadmill test 

Major psychiatric illness 

Ongoing substance abuse 

Active infection 

Active peptic ulcer disease 

Cancer, unless cured or without recurrence for more than 5 years 

HIV Positive 

For psychological or other reasons patient is unable to be maintained on the proposed follow-up schedule 



Health Industry Manufacturers Association
World Leaders in Health Care Innovation
Emerging Medical Technolgies
13 January 1998
Transplantation of Encapsulated Pancreatic Islet Cells Treatment for Insulin-Dependent Diabetics
Product Description Persons experiencing insulin-dependent diabetes will benefit from pancreatic islet cell transplantation, which is a minimally invasive procedure that places human insulin-producing islet cells directly into a small incision in the abdominal cavity. Once implanted, the cells produce a steady amount of insulin. The implant combines insulin-secreting islet cells encapsulated in a porous membrane to recreate continuous, normal physiological glucose monitoring and insulin production without triggering immune rejection. 

VivoRx, Inc. currently has several FDA-approved clinical trials in progress relating to encapsulated cell therapy in Type 1 (insulin-dependent) diabetic patients. VivoRx is now working with a revolutionary micro-gravity bioreactor, developed by NASA, to produce an unlimited supply of proliferated human islets. If successful, this technology will help treat millions of insulin-dependent diabetics around the world. 

Who It Treats  TInsulin-dependent diabetes affects approximately 1.4 million Americans, with nearly 15,000 new cases diagnosed each year. Type 1 diabetes is the third leading cause of death in the United States. It occurs when the body's immune system mistakenly attacks the pancreas, destroying insulin- secreting islet cells. The pancreas monitors and maintains blood glucose levels. Insulin allows body cells to absorb and use sugars in the bloodstream for energy. 

Even with a carefully monitored maintenance program including insulin injections, glucose levels fluctuate above and below the normal range. Blood vessels are severely damaged, putting patients at greater risk for strokes, heart attacks, gangrene of the feet and problems with eyes, kidneys and nerves. 

Benefits With pancreatic islet cells transplanted into the abdomen, the body is able to produce the steady amount of insulin needed to reduce or eliminate the need for insulin injections and reduce or reverse diabetic complications. Because the islet cells are coated in a semi-permeable membrane, the cells are protected from the patient's immune response. At the same time, the membrane allows insulin produced by the islet cells to pass into the patient's bloodstream. 
Contacts  Kathleen Wishner, president, American Diabetes Association, Western Region, Los Angeles, CA (916) 369-0999. 

Katherine Clark, executive director, Foundation for Transplant Research, Los Angeles, CA (800) 407-7266. Patrick Soon-Shiong, M.D., CEO, VivoRx, Inc., Santa Monica, CA (310) 264-7768..

From the Bloomberg Newswire - June 30, 1998

Unfortunately, I think we have our answer regarding the hope offered by Dr. Patrick Soon-Shiong.  Despite his departure from VivoRx and Mylan, it seems that clinical trials are continuing.  However, I understand these trials will simply be using non-expanded, encapsulated human islets in 12 non-immunosuppressed and 12 immunosuppressed recipients.  Is there any truth behind Dr. Soon-Shiong's dramatic claims of expanding human islets? Sadly, I can find no one who believes it.  Here's the story:

Mylan Laboratories Sues Companies Over Diabetes Drug Investment

Los Angeles, June 30 (Bloomberg) -- Mylan Laboratories Inc. sued a
California man and several of his companies, accusing him of diverting much
of $46 million that Mylan invested for diabetes drug research.

The Pittsburgh-based drug maker sued Patrick Soon-Shiong and companies
including American Bioscience Inc. in Los Angeles Superior Court, saying
that Soon-Shiong had wrongly moved some of the money into related companies
that aren't doing diabetes work and that benefited him personally.

The suit says Mylan had invested the money since 1994 to develop cell
encapsulation technology as an alternative to insulin injections in
treating Type I diabetes.

It says it learned of some of the alleged wrongdoing when it saw a private
placement memorandum in which Soon-Shiong was seeking $75 million in new
investments from other parties.

Soon-Shiong couldn't be reached to comment.

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