| CTRI Number |
CTRI/2009/091/000481 [Registered on: 16/07/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Other |
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Public Title of Study
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bone marrow cell treatment for critical limg ischemia |
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Scientific Title of Study
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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
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NCT00595257 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr. K.S. VIjayaraghavan |
| Designation |
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| Affiliation |
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| Address |
747, ponamalle high road,
Prof. & HOD, Dept. of Vascular surgery, Sri Ramachandra University, Porur, Chennai - 600116
Chennai
TAMIL NADU
600010
India |
| Phone |
04426412326 |
| Fax |
|
| Email |
drksv@hotmail.com |
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Details of Contact Person
Scientific Query
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| Name |
T. Anitha |
| Designation |
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| Affiliation |
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| Address |
# 366, Mudichur Road, west Tambaram
TRICell Stem Cell Centre , E1 block,Sri Ramachandra Medical Centre
Chennai
TAMIL NADU
600045
India |
| Phone |
04442040100 |
| Fax |
|
| Email |
anitha@tricell.in |
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Details of Contact Person
Public Query
|
| Name |
T. Anitha |
| Designation |
|
| Affiliation |
|
| Address |
# 366, Mudichur Road, west Tambaram
TRICell Stem Cell Centre , E1 block,Sri Ramachandra Medical Centre
Chennai
TAMIL NADU
600045
India |
| Phone |
04442040100 |
| Fax |
|
| Email |
anitha@tricell.in |
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Source of Monetary or Material Support
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| Harvest Technologies, Boston USA & TRICell Therapeutics Private Limited, Chennai, India. |
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Primary Sponsor
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| Name |
Harvest Technologies, Boston USA |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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| Name |
Address |
| TRICell Therapeutics Private Limited, Chennai, India. |
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. K.S. VIjayaraghavan |
Prof. & HOD, Dept. of Vascular surgery, Sri Ramachandra University, Porur, Chennai - 600116 |
747, ponamalle high road, ,Prof. & HOD, Dept. of Vascular surgery, Sri Ramachandra University, Porur, Chennai - 600116-600010
Chennai
TAMIL NADU |
04426412326
drksv@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Sri Ramachandra University |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Critical Limb Ischemia, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Efficacy of Bone marrow aspirate concentrate in Critical Limb Ischemia |
5 million nucleated cells |
| Intervention |
N/A |
N/A |
| Comparator Agent |
N/A |
N/A |
| Comparator Agent |
To compare the efficacy of bone marrrow aspirate concentrate in patient with critical limb ischemia by altering the mode of administration via Intramuscular & Intra-arterial. |
One Arm: Intramuscular - 40ml of Bone marrow aspirate concentrate; second arm: 20ml of bone marrow aspirate concentrate in intra-muscular & 20 ml of bone marrow aspirate concentrate via Intra-arterial |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
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 considerations
1. No outflow targets
2. No appropriate conduit (i.e. vein for bypass)
3. Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
b. High risk medical conditions
1. Unstable cardiac disease.
2. Renal insufficiency
c. History of prior failed revascularization attempts
d. 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 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.
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| ExclusionCriteria |
| Details |
Subjects will be excluded if they meet any of the 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
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 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)
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Secondary Outcome
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| Outcome |
TimePoints |
| 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
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The following three clinical outcomes will be recorded:
 Subject?s perception of pain (analog pain scale).
 Amputation-free survival
 Pain-free walking distance (claudication) |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/01/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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
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