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

Ischemia Clinical Trial

Official title:

Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498069
• Other study ID #: 2007-1
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: March 17, 2015
• Start date: November 2007
• Est. completion date: March 2015

Study information

• Verified date: June 2014
• Source: Harvest Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The buffy coat is concentrated by removing plasma. The resultant concentrate of cells is injected into ischemic tissues of the lower limb.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• The patient's unsuitability must be confirmed by 2 qualified physicians.

• The attending vascular surgeon will provide the primary assessment.

• The confirmatory opinion must come from a fully licensed physician. (not a resident)

• If anatomical considerations are invoked, the second physician may be a vascular surgeon, interventional radiologist, cardiologist, or vascular medicine specialist.

• If medical co-morbidity is deemed the high risk aspect, then the confirmatory opinion may be obtained from an internist, family physician, cardiologist, vascular medicine, nephrologists, or vascular surgeon.

• Age >18 years and ability to understand the planned treatment

• Subject has read and signed the IRB approved Informed Consent form

• Patients for whom the following medication(s) is prescribed must have a one month stable baseline of appropriate/maximally tolerated therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication

• Hematocrit = 28.0%, White Blood Cell count = 14,000, Platelet count = 50,000, Creatinine = 2.0 mg / dL, INR = 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Ischemia
• Peripheral Arterial Disease

Intervention

Device:
• Harvest Smartprep2 BMAC System
injection of 40cc bmac
• SmartPReP2 BMAC System
Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System

Biological:
• placebo
injection of placebo into ischemic tissue of the lower extremity

Locations

Country	Name	City	State
United States	The Vascular Group at Albany Medical Center	Albany	New York
United States	Tufts Medical Center	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Roper St. Francis Hospital	Charleston	South Carolina
United States	Methodist Hospital	Houston	Texas
United States	University of South Florida Department of Vascular Surgery at Tampa General	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Harvest Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To be determined by data from this feasibility study		3 mos & 5 years	No