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Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200

NCT06003530 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-03-13

No results posted yet for this study

Summary

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).

Conditions

  • Diabetic Foot
  • Diabetic Foot Ulcer
  • Diabetic Foot Ulcer Neuropathic

Interventions

BIOLOGICAL

hOMSC200

Human Oral Mucosal Stem Cells

OTHER

Placebo

Animal component-free, defined cryopreservation medium with 5% DMSO

Sponsors & Collaborators

  • Cytora Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2023-12-19
Completion
2024-12-31

Countries

  • Israel

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 NCT06003530 on ClinicalTrials.gov