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 Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 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.
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
The patient will receive multiple injections in one session during the study. The injections will take place in the chronic wound bed and in the third distal part of the treated shin (in the form of a ring).
Maximal amount of ABMD-MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).
10-20 x 10^6 cells/20mL
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686139
|Contact: Itzhak Siev-Ner, MDfirstname.lastname@example.org|
|Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center||Not yet recruiting|
|Ramat Gan, Israel|
|Contact: Itzhak Siev-Ner, MD 03-530-3701 email@example.com|
|Principal Investigator: Itzhak Siev-Ner, MD|
|Principal Investigator:||Itzhak Siev-Ner, MD||Sheba Medical Center|