Stem Cells Promising for Type 1 Diabetes
Insulin No Longer Needed by Some Diabetic Patients Who Underwent Experimental Treatment
Stem Cells for Diabetes continued...
Patients who remained insulin-independent showed significant improvement in their ability to produce insulin two years after treatment, compared to pre-treatment production levels.
The ability to show direct improvement in insulin-producing cell function is important because critics have questioned whether the treatment really works.
Soon after being diagnosed with type 1 diabetes, many patients enter what is known as a “honeymoon” period, thought to result from improved diet and lifestyle.
It has been suggested that the early improvements seen in the patients who got the stem cell treatment was because of this lifestyle-related remission and not the treatment.
“This treatment actually stopped the autoimmune process and the remaining [insulin-producing] cells that were not destroyed worked well enough to keep many of these patients off insulin,” Nathan says.
FDA Considering Larger Trial
Study co-author Richard Burt, MD, of the Northwestern University Feinberg School of Medicine, concedes that the side effects seen with the treatment were not negligible, but he adds that the approach is far less toxic than immune system-suppressing therapies given to cancer patients.
“I think people will have to judge for themselves if the potential risks of this treatment outweigh the long-term risks associated with type 1 diabetes progression,” he tells WebMD.
The treatment has not been tried in young children. The youngest study participant was 13 and the oldest was 31.
And patients who have had diabetes for some time and no longer produce any beta cells probably would not benefit.
Burt says the next step is to conduct a larger, randomized trial to confirm the usefulness of the treatment in newly diagnosed patients who are still producing some insulin on their own.
The FDA is currently considering whether to allow such a study. The 23 patients who took part in the pilot study were all treated in Brazil.
“This is the first time in the treatment of diabetes that after one intervention patients no longer required any therapy,” Burt says. “And now we have many years of follow-up.”