- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01386216
Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI) (CLI)
Phase I, Non-Randomized, Feasibility Study for the Use of Bone Marrow Cell Concentrate Prepared Using the Magellan System for the Treatment of Critical Limb Ischemia
Study Overview
Status
Intervention / Treatment
Detailed Description
Critical limb ischemia (CLI) continues to be an important cause of atherosclerotic morbidity and mortality despite conventional therapies. Modulation of angiogenesis is a promising alternative to surgical revascularization. Trials of isolated angiogenic growth factor therapies using recombinant proteins or gene transfer have been conducted, but with disappointing results because it is unlikely that a single angiogenic factor is solely or even primarily responsible for angiogenesis. Emerging stem cell therapies represent a new approach to the modulation of angiogenesis. Pluripotent hematopoietic stem cells (HSC) hold promise because they can reproduce a pro-angiogenic milieu in the ischemic limb rather than upregulate a single angiogenic factor.
For this CLI study, the Magellan® System is utilized for the preparation of autologous cell concentrate at the point of care. The bone marrow aspirate is obtained from the patient and concentrated with the cell concentration kit, and delivered intramuscularly to the affected limb for the treatment of impaired ischemic tissue in order to improve perfusion, reduce pain and revascularize tissues in patients who have inadequate tissue blood flow, prohibitive medical comorbidities, or failed previous treatments for revascularization for the prevention of amputation.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Is able to provide written informed consent prior to study entry
- Is male or female, 18 - 85 years of age
- CLI with rest pain, tissue loss, or gangrene
No option for revascularization as a result of one of the following:
- failed previous revascularization, such as recurrent instant restenosis or graft occlusion.
- inadequate target vessels as determined by baseline CTA/angiogram at the time of enrollment.
- or prohibitive medical comorbidities such as high risk cardiovascular or pulmonary disease which would restrict operative procedures
- Final determination of no option for revascularization will be made by a vascular surgeon not associated with the clinical trial.
- ABI less than 0.7, ankle pressure < 50 mmHg, or toe pressure < 30 mmHg.
- TcPO2 < 40 mmHg
- SPP < 35 mmHg
Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):
- Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
- A partner who is physically unable to impregnate the subject (e.g., vasectomized)
- Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to patient's cell concentrate administration,
- Intrauterine device (IUD), or
- Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
- If female is of childbearing potential, subject must have a negative serum pregnancy test at screening
- Confirmation of age-appropriate cancer screening consistent with the American Cancer Society guidelines
Exclusion Criteria:
- Patients with vascular lesions amenable to percutaneous intervention or where surgical bypass is indicated.
- Any contraindication to stem cell or platelet-rich plasma therapy.
- Isolated aorto-iliac stenoses or occlusions without infra-inguinal disease.
- Pregnancy
- Hemoglobin A1c >10 % on day of enrollment.
- Have an active malignancy or have undergone treatment for a malignancy in the preceding 5 years, with the exception of successful treatment of non-melanoma skin cancer.
- Stage 4 or greater chronic kidney disease (eGFR < 30 ml/min, MDRD estimate)
- Hemoglobin < 10 g/dl.
- Thrombocytopenia < 100,000 platelets/µL.
- Unwilling or unable to comply with follow-up visits.
- Proliferative retinopathy as determined by baseline retinal exam.
- Is unable to refrain from nicotine, caffeine and alcohol for a period beginning 24 hours prior to the treatment visit
- Has received an investigational medication or other study trial participation within 30 days prior to the Treatment Visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bone Marrow Cell Concentrate
Bone Marrow Cell Concentrate Prepared Using the Magellan System
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Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to treatment failure or death
Time Frame: Baseline - 12 months
|
Treatment failure is defined as major amputation
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Baseline - 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion and Quality of Life measurements
Time Frame: Baseline - 12 months
|
|
Baseline - 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Go, MD, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART 10-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Limb Ischemia (CLI)
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