bone marrow cell treatment for critical limg ischemia

Phase 3

• Conditions: Critical Limb Ischemia

• Registration Number: CTRI/2009/091/000481
• Lead Sponsor: Harvest Technologies, Boston USA

Brief Summary

The purpose of this feasibility study is to provide clinical data demonstrating the safety and activity of a concentrate of nucleated cells from bone marrow aspirate (BMAC) produced with the Harvest Bone Marrow Aspirate Concentrate System for treating lower limbs of patients diagnosed with critical limb ischemia (CLI) due to peripheral arterial occlusive disease (PAOD). The study will evaluate the hypothesis that BMAC prepared from bone marrow aspirate, when injected intramuscularly and/or intraarterial in areas of ischemia in the lower extremity, has the potential to improve perfusion within the ischemic limb and reduce limb amputation. Sixy (60) study subjects will be enrolled in a prospective, two arm, open label, single center study

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Subjects must meet all of the following inclusion criteria to be enrolled in the trial 1.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)2.Patient meets at least one of the following diagnostic criteria in the study limb:a.Ankle artery occlusion pressure absolute <50 mmHg or ABI <0.4 b.Toe artery occlusive pressure < 40mm Hg or TBI (<0.4)c.TcPO2 <20 mmHg lying down breathing room air, if available.3.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: a.
• Anatomical considerations1.
• No outflow targets2.
• No appropriate conduit (i.e. vein for bypass)3.
• Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
• High risk medical conditions1.
• Unstable cardiac disease.2. Renal insufficiencyc.History of prior failed revascularization attemptsd.The patient?s unsuitability must be confirmed by 2 qualified physicians.1. The attending vascular surgeon will provide the primary assessment.2. The confirmatory opinion must come from a fully licensed physician.
• (not a resident)3.
• If anatomical considerations are invoked, the second physician may be a vascular surgeon, interventional radiologist, cardiologist, or vascular medicine specialist.4. 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.4.Age >18 years and ability to understand the planned treatment5.Subject has read and signed the IRB/IEC approved Informed Consent form 6.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 7.Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, 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

Subjects will be excluded if they meet any of the exclusion criteria:1.Life expectancy <6 months due to concomitant illnesses2.History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation3.Terminal renal failure with existing dependence on dialysis4.Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free..5Poorly controlled diabetes mellitus (HgbA1C>10%)6Medical risk that precludes anesthesia (conscious sedation), or ASA Class 57.Life-threatening complications of the ischemia necessitating immediate amputation8.Uncorrected iliac artery occlusion on index side 9.Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)10.Active clinical infection being treated by antibiotics within one week of enrollment11.Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day).12.Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.13.Underwent a major cardiovascular surgical procedure (carotid endarterectomy, open arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or an adverse cardiovascular event (stroke or MI) within the 30 days prior to randomization.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time points: 6 months; visual analogue pain scale, Quality of life questionaire	The following three clinical outcomes will be recorded:Subject?s perception of pain (analog pain scale).Amputation-free survivalPain-free walking distance (claudication)

Secondary Outcome Measures

Name	Time	Method
Laboratory and Quality of Life EndpointsChange in TcPO2Change in ABI, TBIChange in quality of life (based on Rand-36 questionnaires).Reduction in pain medication	The following three clinical outcomes will be recorded:Subject?s perception of pain (analog pain scale).Amputation-free survivalPain-free walking distance (claudication)

Trial Locations

Locations (1)

Prof. & HOD, Dept. of Vascular surgery, Sri Ramachandra University, Porur, Chennai - 600116; 🇮🇳 Chennai, TAMIL NADU, India

Prof. & HOD, Dept. of Vascular surgery, Sri Ramachandra University, Porur, Chennai - 600116

🇮🇳Chennai, TAMIL NADU, India

Dr. K.S. VIjayaraghavan

Principal investigator

04426412326

drksv@hotmail.com