Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease

Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919516

Enrollment

Registered

2009-06-12

Start date

2007-12-31

Completion date

2013-03-31

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Bone marrow transplantation, Ischemia, Neoangiogenesis, Peripheral arterial disease, Stem cell therapy

Brief summary

The purpose of this study is to evaluate the efficacy of dual intramuscular and intra-arterial autologous bone marrow mononuclear cell implantation for the treatment of patients with moderate to severe peripheral arterial disease in whom amputation was considered the only viable treatment option. Study Hypothesis: Patients with moderate to severe peripheral arterial disease who receive intramuscular and intra-arterial stem cell injections will have improved ankle brachial index (ABI) measurements; relief of rest pain; ulcer healing, if applicable; and absence of major limb amputations.

Interventions

PROCEDUREBone marrow mononuclear cell implantation

Dual intramuscular and intra-arterial injections of bone marrow mononuclear cells harvested from the iliac crest. Injection sites are determined by location of stenosis and/or occlusion on angiogram obtained prior to implantation and typically occur in three medial and three lateral sites approximating the disease location.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients at least 18 years of age. * Patients with moderate or severe limb-threatening PAD, defined as ankle brachial indices (ABI) less than 0.7 or presence of non-healing ischemic ulcers with stenosis or occlusion of two of the following lower extremity arteries: anterior tibial, posterior tibial, and peroneal. * Patients with conditions that preclude recommendation of traditional endovascular or open bypass treatments.

Exclusion criteria

* Patients younger than 18 years of age. * Patients who are eligible to undergo traditional endovascular or open bypass for the treatment of PAD. * Female patients who are or may be pregnant. * Patients who are prisoners. * Patients with mental retardation or are unable to consent for participation independently.

Design outcomes

Primary

Measure	Time frame
Major limb amputation	three months

Secondary

Measure	Time frame
Improved ABI measurements	three months
Relief of rest pain	three months
Ulceration healing	three months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026