Arterial Occlusive DiseasesPhase 1/2NCT00595257
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
A Phase 1/2 study testing centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) in people with Arterial Occlusive Diseases, run by Harvest Technologies at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2007to Apr 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, if available.
Show all 24Show fewer
- 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/IEC 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, 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.
Who cannot join
- 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, Hemocult 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
Show all 13Show fewer
- Life-threatening complications of the ischemia necessitating immediate amputation
- Uncorrected iliac artery occlusion on index side
- 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 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)
- Keywords
- PAD, CLI, Critical Limb Ischemia, bone marrow, stem cell, injection, infusion
- Medical subject headings
- Arterial Occlusive Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)Device
Also called SmartPReP2 BMAC System
autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | injection of BMAC into ischemic limb Receives: Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) |
| 2 | Active comparator | Injection and Infusion of BMAC into ischemic lower limb Receives: Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
avoid amputation
Measured: 60 days
Secondary outcomes (1)
measurement of hemodynamic response
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R E Arasan, MD, Study director, LifeCell India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595257
- Sponsor's protocol ID
- TriCell/CT/IND-001
- Status last verified
- Mar 2012
- First submitted
- 19 Dec 2007
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00595257
- Acronym / sponsor ID
- TriCell/CT/IND-001
- Conditions
- Arterial Occlusive Diseases
- Keywords
- PAD, CLI, Critical Limb Ischemia, bone marrow, stem cell, injection, infusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)injection of BMAC into ischemic limb |
| 2 | Active comparator | Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)Injection and Infusion of BMAC into ischemic lower limb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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:
- Age >18 years and ability to understand the planned treatment
Key exclusion criteria (13 listed)
- 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, Hemocult unless follow-up studies reveal patient to be cancer free..
- Poorly controlled diabetes mellitus (HgbA1C>10%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)Also: SmartPReP2 BMAC Systemautologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs | Device | 1, 2 |
Primary outcome
avoid amputation
Time frame: 60 days
1 secondary outcome
measurement of hemodynamic response
Time frame: 60 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
Related trials for Arterial Occlusive Diseases
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R E Arasan, MD study director
LifeCell India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) in people with Arterial Occlusive Diseases, run by Harvest Technologies at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
avoid amputation (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.