NCT01686139

Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type I Diabetes Mellitus With Ulcer
• Type II Diabetes Mellitus With Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	ABMD-MSC	10-20 x 10\^6 cells/20mL

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2012-09-17
• Last updated: 2016-01-27

Locations

1 site across 1 country: Israel