NCT00392509

ALD-301 for Critical Limb Ischemia, Randomized Trial

A Phase I-II Randomized Autologous Bone Marrow Derived Aldehyde Dehydrogenase-Bright (ALDHbr) Cells Against Unfractionated Autologous Mononuclear Bone Marrow in Patients With Rutherford 4 or 5 Peripheral Arterial Occlusive Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aldagen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will treat patients with such severe lower leg ischemia or vascular compromise that they have pain at rest. The goal is to compare treatment of the patient's painful disorder by injecting cells into the calf of the leg and testing for circulatory improvement. A treatment will given at random to two groups and will be injection into the calf muscle with ALD-301 (specially processed stem and progenitor cells) from the patient's own bone marrow, or with cells processed by more routine that minimally purifies the cells. The study goal is to see if the ALD-301 cells are more effective in generating new small blood vessels to improve the circulation to the affected leg.

Detailed description

Patients will be recruited who have critical limb ischemia with pain at rest. The study will select patients for treatment and follow them for three months after intervention. The treatment will consist of drawing about 2/3 of a cup of bone marrow from the patient's hip bone, then processing the collected bone marrow will be as follows: * The test group's bone marrow will be processed and sorted to identify the aldehyde dehydrogenase bright ALDH-br stem and progenitor cells (ALD-301). These cells will be injected into the calf muscle of the patient in clinic. * The control group will have the same amount of bone marrow collected but it will undergo a simpler process to isolate the mononuclear cells from the whole bone marrow, removing most of the red cells and granulocytes from cell preparation for injection. The patients will be monitored for adverse events related to this process to determine the safety of the approach. They will also be tested at intervals during the study to compare baseline values of each patient with the post-treatment values of: 1. ankle-brachial index of systolic blood pressure 2. the transcutaneous oxygen measurements obtained from the skin of the treated leg 3. the patient's perception of his/her quality of life as measured by two different, validated questionnaires 4. Measurements of of heel/foot ulcers, if present, to monitor degree of healing if it occurs 5. the patient's perception of his/her level of pain in the leg The patients will receive a call at 6 months to report on additional life events following the study.

Conditions

• Critical Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
PROCEDURE	ALDH-br bone marrow cells vs. mononuclear bone marrow cells	Surgery

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-10-26
• Last updated: 2009-05-14

Locations

5 sites across 1 country: United States