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Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia

NCT04661644 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-30

No results posted yet for this study

Summary

This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy of the investigational product(A cluster of adipose-derived mesenchymal stem cells (3D-A) (cluster of adipose- derived mesenchymal stem cells)) and proceeds in that order.

Conditions

  • Critical Limb Ischemia

Interventions

BIOLOGICAL

Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)

Dose: 1 x 10\^7 cells/1 mL/vial (1,000 clusters of adipose-derived mesenchymal stem cells)

BIOLOGICAL

Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)

Dose: 1 x 10\^8 cells/1 mL/vial (10,000 clusters of adipose-derived mesenchymal stem cells)

Sponsors & Collaborators

  • Dt&Sanomedics

    collaborator INDUSTRY

  • S.Biomedics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong-Ik Kim, PhD · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2024-04-22
Completion
2024-07-01

Countries

  • South Korea

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 NCT04661644 on ClinicalTrials.gov