Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers
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.
Type I Diabetes Mellitus With Ulcer
Type II Diabetes Mellitus With Ulcer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)|
- Frequency of Adverse Events [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]Frequency and severity of Adverse Events.
- Healing of all wounds in the target limb [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]Healing of all wounds in the target limb (percentage of wound size reduction). Measurements of wound size and wound grading using the University of Texas Diabetic Wound Classification scale
- Reduced pain [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]Reduced pain, measured by VAS scale and use of analgesics.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
The patient will receive multiple IM injections in one session during the study.
The injections will take place in the thigh and shin of the treated leg (in the form of a ring), and in the chronic wound bed.
Total amount of ABMD-MSC cells: 2x10^6 cells (up to the total volume of 10mL, each 0.5 mL injection contains 1x10^5 cells of ABMD-MSC).
|Contact: Miri Rosenhouse, B. Sc.||email@example.com|
|Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel|
|Contact: Miri Rosenhouse, B.Sc. 03-530-3701 firstname.lastname@example.org|
|Principal Investigator: Itzhak Siev-Ner, MD|
|Principal Investigator:||Itzhak Siev-Ner, MD||Sheba Medical Center|