Clinical trial NCT00919516: Autologous Bone Marrow Mononuclear Cell Implantation for Moderate to Severe Peripheral Arterial Disease
Official title: Use of Autologous Bone-Marrow Mononuclear Cell Implantation Therapy as a Limb Salvage Procedure in Patients With Moderate to Severe Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Bone marrow transplantation
Ischemia
Neoangiogenesis
Peripheral arterial disease
Stem cell therapy
Lead sponsor: The Vascular and Vein Center, Columbus, OH
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major limb amputation
timeFrame: three months
Secondary outcomes:
measure: Improved ABI measurements
timeFrame: three months
measure: Relief of rest pain
timeFrame: three months
measure: Ulceration healing
timeFrame: three months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Vascular and Vein Center
state: Ohio
Study officials:
affiliation: The Vascular and Vein Center
name: Randall W Franz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franz RW, Parks A, Shah KJ, Hankins T, Hartman JF, Wright ML. Use of autologous bone marrow mononuclear cell implantation therapy as a limb salvage procedure in patients with severe peripheral arterial disease. J Vasc Surg. 2009 Dec;50(6):1378-90. doi: 10.1016/j.jvs.2009.07.113. Epub 2009 Oct 17.
citation: Franz RW, Shah KJ, Pin RH, Hankins T, Hartman JF, Wright ML. Autologous bone marrow mononuclear cell implantation therapy is an effective limb salvage strategy for patients with severe peripheral arterial disease. J Vasc Surg. 2015 Sep;62(3):673-80. doi: 10.1016/j.jvs.2015.02.059.