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

• ClinicalTrials.gov Identifier: NCT06003530
• Recruitment Status: Active, not recruiting
• First Posted: August 22, 2023
• Last Update Posted: March 13, 2024
• Sponsor: Cytora Ltd.
• Information provided by (Responsible Party): Cytora Ltd.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic	Biological: hOMSC200; Other: Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be allocated to one of the following arms: Low dose single administration of hOMSC200, High dose single administration of hOMSC200 or Placebo (control) all in addition to SOC treatment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200
• Actual Study Start Date: January 6, 2022
• Actual Primary Completion Date: December 19, 2023
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Treatment related adverse events [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Wound healing [ Time Frame: 24 weeks ]
   Percentage of wound surface area reduction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Israel

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Sponsors and Collaborators

Cytora Ltd.

More Information

• Responsible Party: Cytora Ltd.
• ClinicalTrials.gov Identifier: NCT06003530
• Other Study ID Numbers: Cyt DFU hOMSC200
• First Posted: August 22, 2023
• Last Update Posted: March 13, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cytora Ltd.:

diabetic foot ulcer; stem cells

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases