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

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06003530
• Other study ID #: Cyt DFU hOMSC200
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Cytora Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• hOMSC200
Human Oral Mucosal Stem Cells

Other:
• Placebo
Animal component-free, defined cryopreservation medium with 5% DMSO

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Cytora Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound healing	Percentage of wound surface area reduction	24 weeks