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

Diabetic Foot Ulcer Clinical Trial

Official title:
Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200

Clinical Trial 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).

Clinical Trial Description

A prospective, placebo controlled, partially blinded and randomized study, comprising two hOMSC200 dose groups (low & high) and one placebo treated group of DFU patients (3 groups; n=8 / treatment groups and n=6/ control group). Study employs a 2+2 design for dose escalation. The first two patients recruited were treated with a low dose, in a staggered manner, followed by two patients who were recruited to receive the high dose. The remaining patients (18) are randomized to receive the low dose, high dose, or placebo treatment. The assessors and patients will be blinded to the study treatments. Following administration of hOMSC200 or placebo patients will attend on-site follow up visits for 6 months. During this period safety profile of the investigational product will be assessed as well as measurement of ulcer size. All patients, irrespective of allocated treatment, will receive routine standard of care. Patients will be followed for long term safety with a phone call interview 1 year following the 6 months termination visit. Optional on-site follow up visits will be offered to all patients during this time period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06003530
Study type Interventional
Source Cytora Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date January 6, 2022
Completion date December 31, 2024
View Details
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