Cord blood stem cells improved metabolic control in type 1 diabetes
Umbilical cord blood stem cells have been successful in the treatment of type 1 diabetes, according to a press release from Cord Blood America Inc.
The stem cells have been used to re-instruct T cells so that the pancreas will begin producing insulin again, thereby reducing the amount of injected insulin needed. According to the release, the treatment was successful in long-time diabetes patients believed to have no insulin-producing ability.
Results from a phase 1/phase 2, open-label clinical trial published in the January issue of BMC Medicine demonstrated that Stem Cell Educator, an in vivo cord blood stem cell treatment, reversed autoimmunity and promoted the regeneration of islet beta cells in patients with type 1 diabetes.
“Successful immune modulation by cord blood stem cells and the resulting clinical improvement in patient status may have important implications for other autoimmune and inflammation-related diseases without the safety and ethical concerns associated with conventional stem cell-based approaches,” the researchers wrote.
The study, conducted in China, included 15 patients at a median age of 29 years and a median diabetic history of 8 years.
The procedure circulated patients’ blood through a closed-loop system that separates lymphocytes from whole blood and briefly co-cultures them with adherent cord blood stem cells before returning them to the patient’s circulation, according to the researchers. Patients were randomly assigned to a single treatment (n=12) or a single treatment without adherent cord blood stem cells (sham therapy; n=3). The primary endpoints were feasibility of therapy, safety through 12 weeks of post-treatment and preliminary efficacy evaluation for the improvement of beta-cell function through 24 weeks.
There were no adverse events associated with the procedure, which was well tolerated in all patients with minimal pain from two venipunctures, the researchers wrote.
Patients with moderate type 1 diabetes and some residual beta-cell function demonstrated improved fasting C-peptide levels at 12 and 24 weeks after treatment (mean increase of 0.42 ng/mL at 12 weeks). Those with severe type 1 diabetes and no residual pancreatic islet beta-cell function also had improved fasting C-peptide levels at each follow-up (mean increase of 0.21 ng/mL at 12 weeks).
At 4 and 12 weeks, C-peptide response improved after a 75 g oral glucose tolerance test in patients with moderate disease and some residual beta-cell function. According to the researchers, patients with severe type 1 diabetes and no residual pancreatic islet beta-cell function had essentially no C-peptide production after the glucose challenge at baseline, but had improvements at 12 weeks. This improvement was maintained 40 weeks after treatment (P=.026). In the sham group, there was no significant change at any follow-up endpoint.
Twelve weeks after treatment, the median daily dose of insulin was reduced by 38% in patients with moderate disease and some residual beta-cell function, and 25% in those with severe disease and no residual beta-cell function. The reduced daily insulin dose was maintained through 24 weeks in both sets of patients.
Additionally, HbA1c was reduced from 8.73% at baseline to 7.67% at 4 weeks after treatment (P=.036) and to 6.82% at 12 weeks after treatment (P=.019) in the moderate disease. Median HbA1c was reduced 1.68% in patients with severe disease. There was no significant change in HbA1c observed in the sham group (P=.86).
“This trial provides powerful evidence that exposing a patient’s lymphocytes to cord blood stem cells can achieve the two essential outcomes required to cure type 1 diabetes: reversal of autoimmunity and regeneration of islet beta cells,” the researchers wrote. “However, longer post-treatment observations with larger samples are needed.”
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Disclosure: The researchers report no relevant financial disclosures.
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