Peripheral Artery DiseasePhase 1/2ACT34-CLINCT00616980
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
A Phase 1/2 study testing CD34-positive cells and Saline and 5% autologous plasma in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Losordo, Douglas, M.D. at 12 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- What is being tested?
- CD34-positive cells and Saline and 5% autologous plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2007to Aug 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-80 years of age
- moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
- unsuitable for conventional revascularization
Who cannot join
- advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
- advance AV block or NYHA Class III or Class IV heart failure
- myocardial infarction within 3 months of treatment
- successful coronary or lower extremity revascularization within 3 months of study enrollment
- arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
- co-morbidity associated with life expectancy of less than 1 year
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Cardiology, PC
Birmingham, Alabama, 35211
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Northwestern University
Chicago, Illinois, 60611
University Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, 44106
Florida Research Network LLC
Gainsville, Florida, 32605
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Comprehensive Cardiovascular Care St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Mount Sinai School of Medicine Division of Vascular Surgery
New York, New York, 10029
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Utah-Vascular Surgery Division
Salt Lake City, Utah, 84132
Swedish Medical Center
Seattle, Washington, 98122
About this study
Official title: Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
- Being tested
- CD34-positive cells, Saline and 5% autologous plasma
- Keywords
- PAD, PVD, CLI, Stem Cells
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD34-positive cellsBiological
CD34-positive cellsBiological
Saline and 5% autologous plasmaBiological
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | Not described Receives: Biological: CD34-positive cells |
| High Dose | Active comparator | Not described Receives: Biological: CD34-positive cells |
| Saline | Placebo comparator | Not described Receives: Biological: Saline and 5% autologous plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Intramuscular Injection of CD34-positive cells
Measured: 6 months and 1 year
Change in Rest Pain
Measured: 6 months
Ulcer Healing
Measured: 6 months
Functional Improvement
Measured: 6 months
Limb Salvage
Measured: 6 months
Secondary outcomes (2)
Disease Severity
Measured: 6 months
Assessment of Co-morbidity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Losordo, Douglas, M.D.
- Collaborators
- Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616980
- Sponsor's protocol ID
- STU00009937/STU00001469
- Other IDs
- 11931-02
- Acronym
- ACT34-CLI
- Status last verified
- Jul 2011
- First submitted
- 24 Jan 2008
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
PubMed 35802393Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.
PubMed 23192920
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00616980
- Acronym / sponsor ID
- ACT34-CLI / STU00009937/STU00001469
- Keywords
- PAD, PVD, CLI, Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Losordo, Douglas, M.D.
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Feb 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 evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Biological: CD34-positive cells |
| High Dose | Active comparator | Biological: CD34-positive cells |
| Saline | Placebo comparator | Biological: Saline and 5% autologous plasma |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21-80 years of age
- moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
- unsuitable for conventional revascularization
Key exclusion criteria (6 listed)
- advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
- advance AV block or NYHA Class III or Class IV heart failure
- myocardial infarction within 3 months of treatment
- successful coronary or lower extremity revascularization within 3 months of study enrollment
- arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
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 |
|---|---|---|
| CD34-positive cells | Biological | Low Dose |
| CD34-positive cells | Biological | High Dose |
| Saline and 5% autologous plasma | Biological | Saline |
Primary outcome
Safety of Intramuscular Injection of CD34-positive cells
Time frame: 6 months and 1 year
Change in Rest Pain
Time frame: 6 months
Ulcer Healing
Time frame: 6 months
Functional Improvement
Time frame: 6 months
Limb Salvage
Time frame: 6 months
2 secondary outcomes
Disease Severity
Time frame: 6 months
Assessment of Co-morbidity
Time frame: 6 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 25 Jul 2011.
- Derived from this study: PubMed 35802393Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
- Derived from this study: PubMed 23192920Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.
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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.
12 sites 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 CD34-positive cells and Saline and 5% autologous plasma in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Losordo, Douglas, M.D. at 12 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 3 inclusion and 6 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 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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?
Safety of Intramuscular Injection of CD34-positive cells (time frame: 6 months and 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00616980, which also lists 2 linked publications.
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 25 Jul 2011; AzTrials last refreshed its copy on 8 Nov 2026.