Clinical trial NCT00872326: Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Official title: Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Vascular Diseases
Diabetic Foot
Keywords: Diabetes Complications
Lower limb ischemia
Adult stem cells
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2009-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Angiographic evaluation of angiogenesis and vasculogenesis at target limb
timeFrame: 3 months
Secondary outcomes:
measure: Ankle-Brachial pressure index
timeFrame: 3 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University Hospital Virgen Macarena
Study officials:
affiliation: Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro
name: Antonio de la Cuesta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief of Hematology. Hospital Universitario Virgen Macarena
name: Manuel Constantino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chief of Endovascular Unit. Hospital Universitario Virgen Macarena
name: Rafael J Ruiz-Salmeron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Perez-Camacho I, Marcos-Sanchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177.