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Stem Cell Therapy

Stem Cell Therapy for Intermittent Claudication

Phase 1
Waitlist Available
Led By Douglas W. Losordo, M.D.
Research Sponsored by Losordo, Douglas, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months
Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable
Must not have
Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6
Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing whether stem cells can improve blood flow in people with blocked leg arteries and claudication.

Who is the study for?
This trial is for adults over 21 with severe leg pain due to poor blood flow in the lower limbs, known as Severe Intermittent Claudication. Candidates must have had this condition for at least 6 months and have specific non-reconstructable blockages in their leg arteries. Those who've recently had certain vascular procedures or are suitable for other revascularization treatments cannot participate.
What is being tested?
The study tests if injecting one's own stem cells into the affected leg area can improve blood flow and reduce pain when walking. It's a double-blind trial where participants have a higher chance of receiving stem cells rather than a placebo (salt water solution). All participants will go through pre-treatment steps including cell mobilization and collection.
What are the potential side effects?
Potential side effects may include discomfort at injection sites, infection risk from needle use, allergic reactions to the procedure, or unforeseen complications related to stem cell therapy; however, part of the study's aim is to assess safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PAD in my leg due to clogged arteries for at least 6 months.
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I have a blockage in the artery of my leg that cannot be fixed with surgery.
Select...
I have had severe leg pain when walking for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe leg pain or sores due to poor blood flow.
Select...
My leg circulation issues are not due to clogged arteries.
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My iliac artery disease can be treated with a procedure to improve blood flow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 2Active Control1 Intervention
Group II: 1Active Control1 Intervention
Group III: 3Placebo Group1 Intervention

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Who is running the clinical trial?

Losordo, Douglas, M.D.Lead Sponsor
7 Previous Clinical Trials
146 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
28 Patients Enrolled for Peripheral Arterial Disease
Douglas W. Losordo, M.D.Principal InvestigatorNorthwestern University
2 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Autologous CD34+ Stem Cell Injection (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00311805 — Phase 1
Peripheral Arterial Disease Research Study Groups: 2, 1, 3
Peripheral Arterial Disease Clinical Trial 2023: Autologous CD34+ Stem Cell Injection Highlights & Side Effects. Trial Name: NCT00311805 — Phase 1
Autologous CD34+ Stem Cell Injection (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00311805 — Phase 1
~1 spots leftby Sep 2025
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