Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients

In a phase 2 not yet recruiting study, researchers are using autologous mesenchymal stem cells derived from bone marrow to treat patients with early diagnosed type 1 diabetes. The requirement for being included in this study is it be early diagnosed and must have an antibody against beta cells, and the age range is from 8-40 years old. Participants will be split into two groups, one group that receives one injection of treatment and the other group who will receive a placebo. The primary goal of this study is to find a way stem cell therapy can lead to beta cell restoration. The researchers will be measuring any adverse events, changes in blood sugar levels, and any hypoglycemic episodes.


Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes

A completed study in phases 2 and 3, researchers are using stem cell educator therapy; a process where white blood cells are taken from a person’s body and processed through a machine called a stem cell educator to be “educated” by umbilical cord stem cells. The resulting product is immune cells better prepared to help a person fight off immune diseases. This process is considered low risk since it is a person’s own blood being “educated”. This process is also considered very simple, which is helpful in saving people time and money. The results of this study show the therapy was well tolerated with no adverse events. The conclusion is that “a single treatment [of stem cell educator therapy] produces lasting improvement in metabolic control”.



Stem Cells from Human Exfoliated Teeth in Treatment of Diabetic Patients with Significantly Reduced Islet Function

A phase 1 recruiting trial plans to use mesenchymal stem cells from dental pulp to inject in patients three times over the course of the trial. Researchers found that patients in the trial still needed insulin shots after first rounds of injections, however, eventually were able to become less dependent on insulin. The researchers will measure daily intake of insulin afterwards, as well as pancreatic islet function.


Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

A completed study in phase 2 cultures autologous hematopoietic stem cells. Patients will initially receive a condition regimen of cyclophosphamide and fludarabine followed by an intravenous injection of stem cells. The researchers aim to measure C-peptide, glucose, and insulin levels every three months after treatment. After treatment, multiple patients became insulin free and C-peptide levels greatly increased with only 1 acute adverse effect.


Autologous Adult Stem Cells to Patients with Type 1 Diabetes and a Successful Renal Transplant

A completed study in phase 1 uses autologous CD34+ stem cells collected through leukapheresis to be cultured and re-administered after T1DM patients receive a renal transplant. CD34+ stem cells are progenitor cells that can be a marker for primitive progenitor cells, usually hematopoietic cells. The main goal of the researchers was to evaluate the number of adverse events. The results showed to be very promising, one not serious adverse event, insulin levels dropped, and amylase levels rose.



Efficacy and Safety Study of Autologous Hematopoietic Stem Cell Transplantation to Treat New Onset Type 1 Diabetes

A completed study in phase 2 wants to evaluate B-cell preservation following stem cell transplantation, potential factors affecting efficacy of the transplantation, and how can the immune system be reconstituted. Stem cells in this trial are mobilized and then collected and preserved from each patients’ own blood. After conditioning the patients are injected with the treatment and the researchers analyze levels of lymphocytes, plasma hemoglobin, serum C-peptide, and islet antibodies. After treatment, researchers found that patients needed a lower dose of insulin for glycemic control. Three patients actually were independent of insulin for several months after the trial. This study proves that reprogramming the immune system can have potential lasting effects for T1DM patients.


Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy

This recruiting study in phases 1 and 2 use stem cell educator therapy to treat children with T1DM in order to hone in on the origin of the problem with T1DM, the pancreatic islet beta cells that produce insulin. They will be using cord-blood to go through the stem cell educator therapy. The main goal of this study is to evaluate the autoimmune control. The researchers add that in past trials with this method, that it has been well tolerated with no adverse events. A single treatment can have lasting improvement on the immune system and metabolic control.


Stem Cell Educator Therapy in Type 1 Diabetes

The researchers begin to explain in this phase 2, currently recruiting trial how cord blood stem cells have enormous advantages such as no risk, no ethical issues, and rapid availability. Cord blood contains a stem cell called CB-SC which can function in many different biological ways especially in immune function. This study pulls blood from a patient’s median cubital vein in either arm where it is then passed through a Blood Cell Separator. There, the lymphocytes are separated and are treated with CB-SC. The blood is then injected back into the patient’s hand. The whole process takes about 8-9 hours and the researchers are measuring autoimmune control, metabolic control, and islet beta function in the end. This is a follow up study of a previous one where the same controls took place; the conclusions from the previous study indicated that the Stem Cell Educator therapy “reverses autoimmunity and promotes regeneration of islet B cells”.


Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus

The researchers in this completed study in phases 1 and 2 aim to reprogram the immune system with chemotherapy, immunotherapy, and infusion of bone marrow stem cells. The researchers used autologous peripheral blood hematopoietic stem cells mobilized by G-CSF (granulocyte colony stimulating factor). After 2-3 weeks of reprogramming the blood, patients are administered the treatment and followed up on closely for 2 months and then occasionally for 5 years. The researchers wanted to measure C-peptide levels, hemoglobin levels, exogenous insulin dose, and quality of life after treatment. The results of this trial were very promising. Many of the patients became insulin free for a couple months; beta cell function increased in all patients.


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