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Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595257
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
Harvest Technologies

Brief Summary:
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Non Reconstructable Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
Study Start Date : December 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1
injection of BMAC into ischemic limb
Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
Other Name: SmartPReP2 BMAC System

Active Comparator: 2
Injection and Infusion of BMAC into ischemic lower limb
Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
Other Name: SmartPReP2 BMAC System

Primary Outcome Measures :
  1. avoid amputation [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. measurement of hemodynamic response [ Time Frame: 60 Days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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:

    • 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, 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:

    • 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.
  4. Age >18 years and ability to understand the planned treatment
  5. 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:

  1. Life expectancy <6 months due to concomitant illnesses
  2. History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
  3. Terminal renal failure with existing dependence on dialysis
  4. 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..
  5. Poorly controlled diabetes mellitus (HgbA1C>10%)
  6. Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
  7. Life-threatening complications of the ischemia necessitating immediate amputation
  8. 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 enrollment
  11. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595257

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Sri Ramachandra University Medical Center
Porur, Chennai, India, 600 116
Sponsors and Collaborators
Harvest Technologies
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Study Director: R E Arasan, MD LifeCell India

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Responsible Party: Harvest Technologies Identifier: NCT00595257    
Other Study ID Numbers: TriCell/CT/IND-001
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012
Keywords provided by Harvest Technologies:
PAD, CLI, Critical Limb Ischemia, bone marrow, stem cell, injection, infusion
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases