Stem Cell Educator Therapy is an ongoing clinical trial with stem cells from the umbilical cord blood. I am writing about this clinical trial because Dr. Yong Zhao (the study chairman), who developed the Stem Cell Educator technology, with his co-workers, is going to present the clinical data generated from the Spanish cohort (Hospital Universitario Central de Asturias, Oviedo, Spain). The presentation will be on April 14, 2015, at the Immunology of Diabetes Society's 14th International Congress in Munich, Germany, and is titled “Correct the autoimmune memory by Stem Cell Educator therapy in Caucasian type 1 diabetic subjects: phase I/II clinical trial”. Let’s keep an eye on this speech, because if (and this is a big IF) the technology works, this could be an important advancement towards a cure for type 1 diabetes.
In 2012, Dr. Zhao and co-workers reported on clinical studies carried out in China, from October 2010 through January 2011 with 15 subjects with established T1D (subjects mean duration of diabetes ranging from 2-15 years). The results were reported in a paper by Zhao et al. titled “Reversal of type 1 diabetes via islet beta-cell regeneration following immune modulation by cord blood-derived multi-potent stem cells”, BMC Medicine (2012) 10:3. Click on the link to find the published paper: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3322343/pdf/1741-7015-10-3.pdf.
The highlight of the experiment is presented below:
Figure 1. Overview of Stem Cell Educator therapy. A T1D participant (left) is connected to a Blood Cell Separator (right) and the Stem Cell Educator (bottom center) to form a closed system. Lymphocytes isolated from the T1D participant by the Blood Cell Separator travel through the Stem Cell Educator where they come in contact with CB-SCs attached to the interior surfaces of the device. Educated lymphocytes are returned to the patient's blood circulation. CB-SCs, cord blood stem cells; T1D, type 1 diabetes. Figure and legend are taken from Zhao et al.: “Reversal of type 1 diabetes via islet beta-cell regeneration following immune modulation by cord blood-derived multipotent stem cells”. BMC Medicine (2012) 10:3.
Major findings from the clinical trial (the Zhao et al (2012) paper) were:
- The demonstration of the safety and therapeutic efficacy of Stem Cell Educator therapy in T1D patients.
- This technology introduces back into patients’ bodies their own cells after they have been “educated” to behave by co-culturing with donors CB-SCs, while donors CB-SCs stick tightly to the internal surfaces of the device and are not introduced into the patients, thus avoiding any possible side effects.
- Co-culturing patient lymphocytes with CB-SCs reverses autoimmunity, regenerates β cells and leads to better metabolic control (improved C-peptide levels, reduced A1C, and reduced the median dose of insulin) in all T1D patients, those that had β-cells and also in those who seemed lacking β cells prior treatment.
- Though the mechanisms underlying these beneficial and lasting (at least 10 months) effects with a single treatment are not completely understood, it looks like that the CB-SCs in the device modulate the immune response in patients' multiple cell types in such a way that that brings about reversal of immunity.
I believe that, before making any meaningful reliable conclusions about the power of this technology, larger studies with hundreds, or better, thousands patients need to confirm and possibly improve present results. If the results repeat or improve, this technology could be a clear step towards a therapy to cure T1D.
* ClinicalTrials.gov number, NCT01350219