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Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia

NCT03455335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-03-04

No results posted yet for this study

Summary

The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of autologous bone marrow-derived MSCs. Following informed consent, patients who meet the criteria will be screened and enrolled. Up to 100 mls of bone marrow will be harvested from the participant from which MSCs will be culture expanded. In this dose escalation study, 3 participants on each cohort will be treated with a targeted dose of either 20 million hMSC; 40 million hMSC; or 80 million hMSC. The cells will be administered to the ischemic leg by 20 intramuscular injections of approximately 0.5ml per injection . Treatment groups will be completed sequentially, beginning with the lowest dose group.

Conditions

  • Critical Limb Ischemia

Interventions

DRUG

20 million hMSCs

DRUG

40 million hMSCs

DRUG

80 million hMSCs

Sponsors & Collaborators

  • University Hospital of Limerick

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Timothy O Brien, PhD · NUIG

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-23
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455335 on ClinicalTrials.gov