IschemiaNCT00498069
Study of Autologous Bone Marrow Concentrate for the Treatment of Critical Limb Ischemia (CLI)
A study testing Harvest Smartprep2 BMAC System and SmartPReP2 BMAC System in people with Ischemia, run by Harvest Technologies at 6 sites in United States.
Trial summary
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia
- What is being tested?
- Harvest Smartprep2 BMAC System and SmartPReP2 BMAC System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2007to Mar 2015
- Phase
- Interventional
- 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.
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- 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.
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, 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
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Vascular Group at Albany Medical Center
Albany, New York, 12208
Tufts Medical Center
Boston, Massachusetts, 02111
Maimonides Medical Center
Brooklyn, New York, 11219
Roper St. Francis Hospital
Charleston, South Carolina, 29401
Methodist Hospital
Houston, Texas, 77030
University of South Florida Department of Vascular Surgery at Tampa General
Tampa, Florida, 33606
About this study
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
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
Read the detailed 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.
- Conditions
- Ischemia
- Being tested
- Harvest Smartprep2 BMAC System, SmartPReP2 BMAC System, placebo
- Keywords
- Critical limb ischemia due to peripheral arterial occlusive disease, Autologous bone marrow concentrate
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvest Smartprep2 BMAC SystemDevice
Also called SmartPReP2 BMAC System
injection of 40cc bmac
SmartPReP2 BMAC SystemDevice
Injection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System
placeboBiological
injection of placebo into ischemic tissue of the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Injection of autologous bone marrow concentrate into ischemic tissues of the lower extremity Receives: Device: Harvest Smartprep2 BMAC System; Device: SmartPReP2 BMAC System |
| 2 | Placebo comparator | Injection of placebo into ischemic tissues of the lower extremity Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To be determined by data from this feasibility study
Measured: 3 mos & 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498069
- Sponsor's protocol ID
- 2007-1
- Status last verified
- Jun 2014
- First submitted
- 5 Jul 2007
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. 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 Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT00498069
- Acronym / sponsor ID
- 2007-1
- Conditions
- Ischemia
- Keywords
- Critical limb ischemia due to peripheral arterial occlusive disease, Autologous bone marrow concentrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jul 2007 (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.
Injections of concentrated bone marrow mononuclear cells into ischemic tissues will result in vasculogenesis
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Harvest Smartprep2 BMAC System, Device: SmartPReP2 BMAC SystemInjection of autologous bone marrow concentrate into ischemic tissues of the lower extremity |
| 2 | Placebo comparator | Biological: placeboInjection of placebo into ischemic tissues of the lower extremity |
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 (15 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, Hemoccult 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 |
|---|---|---|
| Harvest Smartprep2 BMAC SystemAlso: SmartPReP2 BMAC Systeminjection of 40cc bmac | Device | 1 |
| SmartPReP2 BMAC SystemInjection of autologous bone marrow concentrate prepared with the SmartPReP2 BMAC System | Device | 1 |
| placeboinjection of placebo into ischemic tissue of the lower extremity | Biological | 2 |
Primary outcome
To be determined by data from this feasibility study
Time frame: 3 mos & 5 years
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 19 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvest Smartprep2 BMAC System and SmartPReP2 BMAC System in people with Ischemia, run by Harvest Technologies at 6 sites in United States.
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 15 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To be determined by data from this feasibility study (time frame: 3 mos & 5 years). 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 19 Mar 2015.