Diabetic Foot, Peripheral Vascular Diseases
Conditions
Keywords
Diabetes Complications, Lower limb ischemia, Adult stem cells
Brief summary
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Detailed description
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease. After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes. Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of: * Changes in below-the-knee angiography from baseline to 3 months follow-up. * Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.
Interventions
Infusion \> 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
Sponsors
Carlos III Health Institute
Andalusian Network for Design and Translation of Advanced Therapies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic patients under treatment (type I or II) * Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8) * Not suitable to be revascularized (surgical and interventional consensus)
Exclusion criteria
* Neoplastic disease and/or hematologic disease during the last 2 years * Diabetic retinopathy * Ischemic ulcer greater than 10 cm2 * Major amputation at target limb * Life expectancy \> 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic evaluation of angiogenesis and vasculogenesis at target limb | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Ankle-Brachial pressure index | 3 months |
Countries
Spain
Outcome results
None listed