But in the course of the first year, his insulin requirements gradually rose because about half of the implanted cells died--probably because they were rejected, Formby said.
However, the surviving cells are continuing to produce about 20% of Shultz's daily insulin requirement--enough to smooth out the sharp swings in blood sugar levels and make his disease more manageable.
Before the operation, he said, a milkshake or chocolate bar would cause his blood sugar to rise sharply, making him lethargic. Now, the effects of such sweets are much less severe, he said.
The first scientist to transplant fetal islet cells in humans was immunologist Kevin Lafferty of the University of Colorado Health Sciences Center in Denver, in 1985.
Lafferty refused a request for an interview, but Bobbie Barrow, a university spokeswoman, said in a prepared statement that Lafferty has transplanted cultured cells in 17 insulin-dependent diabetics who had already received kidney transplants because high sugar levels had damaged small blood vessels in their own kidneys. Such patients were already receiving drugs to suppress rejection of the kidney, and were thus less likely to reject the pancreas cells.
Five of seven patients given "large amounts" of the cells required fewer insulin injections after the surgery, Barrow said, some for as long as 1 1/2 years. The treatment provided no benefit for patients who received fewer cells, she added.
The third U.S. group involved in experimental fetal cell transplant is Hana, which has spent the last five years developing ways to grow fetal pancreas cells in the laboratory, according to Craig McMullen, Hana's president.
Using specially developed nutrients and growth enhancers, he said, the company is now able to grow enough cells from one fetal pancreas to treat 20 adult diabetics.
Much More Efficient
With this technique, instead of needing 25 fetal pancreases to treat one adult, Hana can obtain enough islets from one fetal pancreas to treat 20 patients--making its technique 500 times more efficient than Formby's.
To test the safety of those cells--a standard medical practice--surgeons at four medical centers have, since last August, implanted the fetal cells in 24 diabetics, McMullen said. By this September, Hana hopes to expand the trials to 120 patients at 12 medical centers to test the cells' efficacy. McMullen would not reveal the names of the centers because, he said, "we are afraid the centers would be swamped by diabetics demanding treatment."
(Although the implants are not covered by any federal regulations, Hana nevertheless is testing the cells' safety in case the U.S. Food and Drug Administration ultimately were to classify such cells as a drug.)
Hana hopes to be able to provide cells for 15,000 transplants per year by 1991, McMullen said.
The company has also been developing similar techniques to grow fetal brain cells for the treatment of Parkinson's and are now testing them in animals. McMullen said it will be at least 18 months before human trials can begin.
Obtained Fetal Tissues
Initially, Sansum, Lafferty and Hana all obtained fetal tissues from the National Disease Research Interchange (NDRI), a nonprofit, NIH-funded foundation created in 1980.
The Philadelphia-based interchange serves as a clearinghouse primarily for organs and tissues removed during autopsies and surgeries. Such materials are useful in many types of research, and NDRI has provided 32,000 organs to about 350 researchers throughout the country.
Volunteers at NDRI's network of Eastern hospitals obtain informed consent from tissue donors or the mothers of fetuses and notify NDRI of an organ's availability. The agency then notifies researchers who need that tissue, and may help arrange transportation.
But early last year, said Lee Ducat, NDRI president, the foundation's volunteers became reluctant to collect fetal tissues because of a growing fear of pressure from right-to-life groups.
Ducat could not identify any event that precipitated the change in attitude, but said: "We haven't collected any fetal tissue at all since last June. . . . It's very frustrating . . . because we know that the tissue is being . . . thrown away."
Many researchers who received fetal tissues from NDRI are now obtaining them from the even more obscure International Institute for the Advancement of Medicine, a nonprofit foundation established in 1986 by a former NDRI staff member in Havertown, Pa. The institute differs from NDRI in that it rents space in hospitals and clinics and hires its own technicians to process and forward tissues.
In 1987, the institute supplied about 1,800 tissues to researchers, said director Jim Bardsley. So far this year, it has been processing 500 specimens per month--about 60% of them fetal tissues. The institute is now working with 44 research groups that need fetal tissues, he said.
Bardsley would not divulge the names of participating hospitals and clinics because, he said, "We don't want to motivate any aggression."
Like the experimental use of fetal cells, the collection and distribution of the tissues also are not regulated by either the states or the federal government. But activist Jeremy Rifkin of the Foundation on Economic Trends in Washington, has accused both NDRI and Hana of buying and selling fetal tissues, and he has petitioned the Department of Health and Human Services to ban the sale of fetal tissues.