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

NCT ID: NCT00872326

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Peripheral Vascular Diseases Diabetic Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Bone Marrow Mononuclear Cells

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

Group Type EXPERIMENTAL

Autologous Bone Marrow Mononuclear Cells

Intervention Type PROCEDURE

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

Interventions

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Autologous Bone Marrow Mononuclear Cells

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Andalusian Network for Design and Translation of Advanced Therapies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio de la Cuesta, MD

Role: PRINCIPAL_INVESTIGATOR

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

Manuel Constantino, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief of Hematology. Hospital Universitario Virgen Macarena

Rafael J Ruiz-Salmeron, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief of Endovascular Unit. Hospital Universitario Virgen Macarena

Locations

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University Hospital Virgen Macarena

Seville, Seville, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 22289660 (View on PubMed)

Other Identifiers

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FPS C/ICPD/2007

Identifier Type: -

Identifier Source: secondary_id

C/ICPD/2007

Identifier Type: -

Identifier Source: org_study_id