Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type I Diabetes Mellitus With Ulcer
- Sponsor
- Sheba Medical Center
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Frequency of Adverse Events
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Dr. Itzhak Siev-Ner
Head of the Orthopedic Rehabilitation Department
Sheba Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patient signed informed consent.
- •Adult males or females between 18 and 81 years of age with diabetes mellitus type 1 or type
- •Patient has one Diabetic Foot Ulcer (DFU) on the treated leg. The size of the DFU is no greater than 10 cm2 .
- •The Diabetic Foot Ulcer (DFU) is neuropathic: The patient is checked by a 5.27 mm Monofilament, and doesn't have a sensation in at least 4 of 9 points in the foot.
- •No endovascular or surgical interventions are planned.
- •Patient isn't in an immediate life threat.
- •Normal organ and marrow function as defined:
- •Leukocytes ≥3,000/μL
- •Absolute neutrophil count ≥1,500/μL
- •Platelets ≥140,000/μL
Exclusion Criteria
- •Patient weight is greater than 120 Kg.
- •Patients with poorly controlled diabetes mellitus (HbA1c \> 10%).
- •Presence of osteomyelitis (stage B grade 3 and stage D grade 3 on the UT Scale).
- •More than one ulcer in the treated foot.
- •Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment.
- •Patients with ABI \<= 0.3
- •Patients receiving treatment with hematopoietic growth factors.
- •(Actively) infected ulcer.
- •Infection of the involved extremity(ies) in the intended region of injection. Patient will be included (injected) if there is a safe zone of 10 cm from any soft tissue infection, manifested by fever, purulence and severe cellulitis.
- •Active wet gangrenous tissue.
Outcomes
Primary Outcomes
Frequency of Adverse Events
Time Frame: 6 months after treatment
Frequency and severity of Adverse Events.