Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes
Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.
Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.
The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.
This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.
|Type 1 Diabetes Mellitus||Procedure: autologous bone marrow implantation Other: Saline injection||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Método Para Regenerar el páncreas Con localización in Vivo de médula ósea Total Autologa en Pacientes diabéticos Tipo 1. Estudio Fase IIB.|
- Significant increase in C-peptide levels after transplant in 70% of the patient. [ Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months ]
- Reduction by 50% of the insulin requirement after the transplant in 70% of the patients. [ Time Frame: Two years ]
- Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels. [ Time Frame: one year ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Sham Comparator: saline injection||
Other: Saline injection
Injection of saline solution for 5 days
|Experimental: Autologous bone marrow implantation||
Procedure: autologous bone marrow implantation
Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971503
|School of Medicine, Pontificia Universidad Catolica de Chile|
|Santiago de Chile, Chile|
|Principal Investigator:||Alejandro D. Mesples, MD||University of Morón, School of Medicine|