Stem Cells: Under the MicroscopeType 1 Diabetes: Landmark Clinical Trial Exploring Cord Blood Stem Cells as Therapy
1) regenerating islet-producing cells;
2) protecting existing insulin-producing cells;
3) controlling the body's immune response.
Nearly 21 million Americans have some form of diabetes, a disease in which the body does not produce or properly use insulin, resulting in high blood glucose levels. In the case of type 1 diabetes, the body's immune system destroys insulin-producing beta cells in the pancreas. While disease onset can occur at any age, type 1 diabetes is particularly prevalent in children — one in 300 children is affected by diabetes, and the incidence is increasing three to five percent annually.
To help address this startling trend, the University of Florida initiated a phase I/II clinical trial to examine how an infusion of autologous (or one's own) cord blood stem cells into children with diabetes will impact metabolic control over time, as compared to standard intensive insulin treatments. Researchers just presented compelling observational data from this trial, which show promising results, at the American Diabetes Association's 67th Scientific Sessions.
Preliminary results presented by the study's primary investigator, Dr. Michael J. Haller, demonstrate an infusion of cord blood stem cells reduced patients' disease severity, possibly re-setting the immune system and slowing destruction of insulin-producing beta cells in the pancreas. Children in the study who received the infusion of their own cord blood stem cells had lower blood sugar levels and required less insulin than the control group. Over a six-month observation period, these children continued producing their own insulin longer than expected and, therefore, may be at lower risk for diabetes complications over the length of their lifetime.
Diabetes can lead to debilitating or life-threatening conditions including heart disease, stroke, blindness, kidney disease, and amputations. Currently, it is the fifth leading cause of death by disease in the U.S. Consider this:
| Each Year: | |
| 1 in 7,000 | Children develop type 1 diabetes |
| 20.6 million | Americans are living with diabetes |
| 12,000 24,000 | New cases of blindness are caused by diabetes |
| In 2002: | |
| 224,000 | Deaths were associated with diabetes |
| 44,000 | People with diabetes were treated for end-stage renal disease |
Cord blood is being considered a strong candidate for diabetes therapy for two reasons: 1) the stem cells in cord blood are capable of differentiating into insulin-producing cells and 2) cord blood contains cells that may help prevent the progressive "self-destruction" of the existing insulin-producing cells in the pancreas.
Earlier animal studies using cord blood to treat diabetes also have delivered positive results. In an unrelated trial, mice with type 1 and type 2 diabetes that received an infusion of cord blood stem cells had decreased glucose levels, improved survival curve, and reduced insulitis.Although further study is needed to determine just how cord blood yields benefits in treating diabetes in humans, it is just one of a growing number of regenerative stem cell therapies that are moving from the lab into the clinic. Regenerative medicine studies are underway for a variety of conditions including heart disease, stroke, Parkinson's disease, spinal cord injury, amyotrophic lateral sclerosis, muscular dystrophy and liver disease.
