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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic
• Intervention / Treatment: Biological: hOMSC200; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks.
• Size of foot ulcer 0.5-13 cm2
• Ulcer graded I by Wager scale
• Ulcer is free of necrotic debris, exhibits no signs of clinical infection
• Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis anterior and posterior arteries in the affected foot; B. ABI range >0.7 to <1.3; C. TcPO2>30mmHg

Exclusion Criteria:

• Ulcer is of non-diabetic pathophysiology
• The ulcer has decreased in size by >=30% after the screening visit (week -2 to -4 before treatment)
• Severe hepatic deficiency
• Glycated hemoglobin A1C (HbA1C) level of >12%
• Postprandial blood sugar > 350mg/dl
• Require antibiotics to treat the target wound infection within 14 days prior to treatment
• Evidence of current wound infection including pus drainage from wound site
• Severe renal failure (GFR<30) including subject on renal dialysis
• Pregnant or breastfeeding
• Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening
• Patient receiving anticoagulation therapy except for aspirin
• Underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose hOMSC200; Administration of low dose hOMSC200 in addition to routine standard of care	Biological: hOMSC200; Human Oral Mucosal Stem Cells
Experimental: High dose hOMSC200; Administration of high dose hOMSC200 in addition to routine standard of care	Biological: hOMSC200; Human Oral Mucosal Stem Cells
Placebo Comparator: Placebo; Administration of placebo in addition to routine standard of care	Other: Placebo; Animal component-free, defined cryopreservation medium with 5% DMSO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment related adverse events	Occurrence of treatment-related adverse events assessed by common terminology criteria for adverse events (CTCAE) following recruitment, hOMSC200 administration (ID), and during the follow up.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Percentage of wound surface area reduction	24 weeks

Collaborators and Investigators

• Sponsor: Cytora Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): December 19, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: stem cells; diabetic foot ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: Cyt DFU hOMSC200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No