Type I Diabetes Mellitus With Ulcer Clinical Trial
Official title:
Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)
Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world.
DM contributes to severe morbidity and mortality due to damage in the target organs
(neuropathy, vasculopathy, nephropathy, retinopathy).
It affects the quality of life of the patients because of increased rate of blindness, IHD,
stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic
Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic
patients due to neurological damage and / or different levels of Peripheral Vascular Disease
(PVD). Diabetic foot complications are the most common cause of lower extremity amputations
in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in
diabetic patients.
Between 15% - 25% of the foot ulcers will lead to lower limb amputations.
It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many
diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and
critical limb ischemia.
Stem cells can be obtained from either the patient (autologous) or non-related healthy
donors (allogeneic).
The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow
Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg
wounds of diabetic patients.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment