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

NCT06003530 | Active Not Recruiting Phase 1

• 1 other identifier: Cyt DFU hOMSC200
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot; Diabetic Foot Ulcer; Diabetic Foot Ulcer Neuropathic

Keywords

diabetic foot ulcer; stem cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound healing

  24 weeks

Study Arms (3)

Low dose hOMSC200

EXPERIMENTAL

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

Biological: hOMSC200

High dose hOMSC200

EXPERIMENTAL

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

Biological: hOMSC200

Placebo

PLACEBO COMPARATOR

Administration of placebo in addition to routine standard of care

Other: Placebo

Interventions

hOMSC200 BIOLOGICAL

Human Oral Mucosal Stem Cells

High dose hOMSC200; Low dose hOMSC200

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytora Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: January 6, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

IL (1)