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

NCT ID: NCT06003530

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low dose hOMSC200

Administration of low dose hOMSC200 in addition to routine standard of care

Group Type: EXPERIMENTAL

hOMSC200

Intervention Type: BIOLOGICAL

Human Oral Mucosal Stem Cells

High dose hOMSC200

Administration of high dose hOMSC200 in addition to routine standard of care

Group Type: EXPERIMENTAL

hOMSC200

Intervention Type: BIOLOGICAL

Human Oral Mucosal Stem Cells

Placebo

Administration of placebo in addition to routine standard of care

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

hOMSC200

Human Oral Mucosal Stem Cells

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytora Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Cyt DFU hOMSC200

Identifier Type: -

Identifier Source: org_study_id