NCT06003530

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cytora Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	hOMSC200	Human Oral Mucosal Stem Cells
OTHER	Placebo	Animal component-free, defined cryopreservation medium with 5% DMSO

Timeline

• Start date: 2022-01-06
• Primary completion: 2023-12-19
• Completion: 2024-12-31
• First posted: 2023-08-22
• Last updated: 2024-03-13

Locations

1 site across 1 country: Israel