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.

Tracking Information

• First Submitted Date: August 15, 2023
• First Posted Date: August 22, 2023
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: January 6, 2022
• Actual Primary Completion Date: December 19, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 15, 2023)

Wound healing [ Time Frame: 24 weeks ]

Percentage of wound surface area reduction

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

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

Condition

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

Intervention

• Biological: hOMSC200
  Human Oral Mucosal Stem Cells
• Other: Placebo
  Animal component-free, defined cryopreservation medium with 5% DMSO

Study Arms

• Experimental: Low dose hOMSC200
  Administration of low dose hOMSC200 in addition to routine standard of care
  Intervention: Biological: hOMSC200
• Experimental: High dose hOMSC200
  Administration of high dose hOMSC200 in addition to routine standard of care
  Intervention: Biological: hOMSC200
• Placebo Comparator: Placebo
  Administration of placebo in addition to routine standard of care
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 11, 2024): 21
• Original Estimated Enrollment (submitted: August 15, 2023): 22
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: December 19, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT06003530
• Other Study ID Numbers: Cyt DFU hOMSC200
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cytora Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Cytora Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cytora Ltd.
• Verification Date: March 2024