Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)

NCT00498069 | Completed

• 1 other identifier: 2007-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis

Conditions

Ischemia

Keywords

Critical limb ischemia due to peripheral arterial occlusive disease; Autologous bone marrow concentrate

Outcome Measures

Primary Outcomes (1)

• To be determined by data from this feasibility study

  3 mos & 5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Injection of autologous bone marrow concentrate into ischemic tissues of the lower extremity

Device: Harvest Smartprep2 BMAC System; Device: SmartPReP2 BMAC System

2

PLACEBO COMPARATOR

Injection of placebo into ischemic tissues of the lower extremity

Biological: placebo

Interventions

Harvest Smartprep2 BMAC System DEVICE

injection of 40cc bmac

Also known as: SmartPReP2 BMAC System

1

SmartPReP2 BMAC System DEVICE

Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System

1

placebo BIOLOGICAL

injection of placebo into ischemic tissue of the lower extremity

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Critical Limb Ischemia per protocol (see diagnostic criteria #2) with regard to the study limb.
• Existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 or Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons (table 1)
• Patient meets at least one of the following diagnostic criteria in the study limb:
• Ankle artery occlusion pressure absolute \<50 mmHg or ABI \<0.4
• Toe artery occlusive pressure \< 40mm Hg or TBI (\<0.4)
• TcPO2 \<20 mmHg lying down breathing room air.
• There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
• Anatomical considerations
• No outflow targets
• No appropriate conduit (i.e. vein for bypass)
• Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
• High risk medical conditions
• Unstable cardiac disease.
• Renal insufficiency
• History of prior failed revascularization attempts

You may not qualify if:

• Life expectancy \<6 months due to concomitant illnesses
• History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
• Terminal renal failure with existing dependence on dialysis
• Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free..
• Poorly controlled diabetes mellitus (HgbA1C\>10%)
• Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
• Life-threatening complications of the ischemia necessitating immediate amputation
• Uncorrected iliac artery occlusion on index side
• No Doppler signal in the foot (ABI =0)
• Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
• Active clinical infection being treated by antibiotics within one week of enrollment
• Treatment with immunosuppressant drugs (including Prednisone \> 5 mg per day).
• Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
• Underwent a major open cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or a myocardial infarction within the 3 months prior to randomization
• Cerebrovascular accident within 6 months prior to randomization.

Sponsors & Collaborators

• Harvest Technologies: lead

Study Sites (6)

University of South Florida Department of Vascular Surgery at Tampa General

Tampa, Florida, 33606, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

The Vascular Group at Albany Medical Center

Albany, New York, 12208, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Roper St. Francis Hospital

Charleston, South Carolina, 29401, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 9, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 19, 2015

Record last verified: 2014-06

Locations

US (6)