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Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia

Primary Purpose

Peripheral Vascular Diseases, Diabetic Foot

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Autologous Bone Marrow Mononuclear Cells

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Diabetes Complications, Lower limb ischemia, Adult stem cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Virgen Macarena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Bone Marrow Mononuclear Cells

Arm Description

Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells

Outcomes

Primary Outcome Measures

Angiographic evaluation of angiogenesis and vasculogenesis at target limb

Secondary Outcome Measures

Ankle-Brachial pressure index

Full Information

NCT ID

NCT00872326

First Posted

March 30, 2009

Last Updated

November 13, 2014

Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Collaborators

Carlos III Health Institute

1. Study Identification

Unique Protocol Identification Number

NCT00872326

Brief Title

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

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Collaborators

Carlos III Health Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Diseases, Diabetic Foot

Keywords

Diabetes Complications, Lower limb ischemia, Adult stem cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous Bone Marrow Mononuclear Cells

Arm Type

Experimental

Arm Description

Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells

Intervention Type

Procedure

Intervention Name(s)

Autologous Bone Marrow Mononuclear Cells

Intervention Description

Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.

Primary Outcome Measure Information:

Title

Angiographic evaluation of angiogenesis and vasculogenesis at target limb

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Ankle-Brachial pressure index

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio de la Cuesta, MD

Organizational Affiliation

Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manuel Constantino, PhD

Organizational Affiliation

Chief of Hematology. Hospital Universitario Virgen Macarena

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rafael J Ruiz-Salmeron, PhD

Organizational Affiliation

Chief of Endovascular Unit. Hospital Universitario Virgen Macarena

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Virgen Macarena

City

Seville

ZIP/Postal Code

41007

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

22289660

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.

Results Reference

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Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia

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