Critical Limb Ischemia (CLI)Phase 1CLINCT01386216
Safety Study of Bone Marrow Cell Concentrate Prepared Using the Magellan System to Treat Critical Limb Ischemia (CLI)
A Phase 1 study testing Magellan® in people with Critical Limb Ischemia (CLI) and Peripheral Vascular Disease (PVD), run by Arteriocyte, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia (CLI), Peripheral Vascular Disease (PVD)
- What is being tested?
- Magellan®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2016
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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
The purpose of this study is to evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
Read the 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.
- Being tested
- Magellan®
- Keywords
- Critical limb ischemia, Peripheral vascular disease, platelet-rich plasma
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magellan®Device
Also called autologous cell concentrate
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Cell Concentrate | Experimental | Bone Marrow Cell Concentrate Prepared Using the Magellan System Receives: Device: Magellan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure or death
Treatment failure is defined as major amputation
Measured: Baseline - 12 months
Secondary outcomes (1)
Perfusion and Quality of Life measurements
- Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
- Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
- Perfusion rate in treated tissue by skin perfusion pressure (SPP)
- Pain intensity using Visual Analogue Scale (VAS)
- Quality of Life (QoL) by questionnaire
Measured: Baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb Ischemia (CLI)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arteriocyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Go, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386216
- Sponsor's protocol ID
- ART 10-001
- Acronym
- CLI
- Status last verified
- Jan 2017
- First submitted
- 29 Jun 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01386216
- Acronym / sponsor ID
- CLI / ART 10-001
- Keywords
- Critical limb ischemia, Peripheral vascular disease, platelet-rich plasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arteriocyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 1 Jul 2011 (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 evaluate the safety of administration of marrow-derived autologous hematopoietic stem cells (HSC) concentrate and platelet-rich plasma (PRP) gel for the treatment of Critical Limb Ischemia (CLI).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Cell Concentrate | Experimental | Device: Magellan®Bone Marrow Cell Concentrate Prepared Using the Magellan System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- ABI less than 0.7, ankle pressure < 50 mmHg, or toe pressure < 30 mmHg.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Magellan®Also: autologous cell concentrateAutologous 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. | Device | Bone Marrow Cell Concentrate |
Primary outcome
Time to treatment failure or death
Time frame: Baseline - 12 months
Treatment failure is defined as major amputation
1 secondary outcome
Perfusion and Quality of Life measurements
Time frame: Baseline - 12 months
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 24 Jan 2017.
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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.
Michael Go, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magellan® in people with Critical Limb Ischemia (CLI) and Peripheral Vascular Disease (PVD), run by Arteriocyte, Inc. at 1 site 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 19 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 24 Jan 2017. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Time to treatment failure or death (time frame: Baseline - 12 months). 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 24 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.