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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12, month 6, month 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I have had severe leg pain when walking for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12, month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12, month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, month 6, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Intramuscular administration of CD34-positive cells

Secondary outcome measures

Functional improvement

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 2Active Control1 Intervention

Group II: 1Active Control1 Intervention

Group III: 3Placebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent can individuals be adversely affected by two?

"Due to the initial nature of this clinical trial, our team has rated its safety at a 1. This is because Phase 1 trials lack extensive data demonstrating efficacy and safety."

Answered by AI

Is this experiment actively seeking participants?

"As per clinicaltrials.gov, this particular study is not currently enrolling participants; the trail was initially posted in April of 2006 and last updated on March 30th 2015. Fortunately, there are 230 other medical trials actively searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)

2006. "Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00311805.

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