Autologous bone marrow cells in patients with critical limb ischemia

Completed

• Conditions: Critical limb ischemia; Circulatory System

• Registration Number: ISRCTN16096154
• Lead Sponsor: ational Institute of Heart and Vascular Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-26
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Patients over 18 years of age
2. With ischemic skin lesions (ulcers or gangrene) with a Critical limb ischemia Rutherford category of 5 or 6 according to the TransAtlantic InterSociety Consensus (TASC) classification (minor or major tissue loss)
3. Critical limb ischemia defined by ankle–brachial index =0.4, or ankle systolic pressure <50 mmHg, or toe systolic pressure <30 mmHg, or transcutaneous oxygen pressure (tcpO2) <30 mmHg
4. No option for endovascular or surgical revascularization assessed by a vascular surgeon and interventionalist
5. Failed revascularization defined as no change of clinical status with the best standard care 4 weeks after endovascular or surgical revascularization

Exclusion Criteria

1. Life expectancy <6 months
2. Evidence of malignancy during last 5 years
3. Proliferative retinopathy
4. Critical coronary artery disease or unstable angina pectoris
5. End-stage kidney disease and patient on dialysis
6. Bone-marrow disease (e.g., myelodysplastic syndrome, severe anemia, leukopenia, thrombocytopenia)

Study & Design

• Study Type: Interventional
• Study Design: Not specified