Clincosm LogoSign in Get a demo

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

Sponsor
Cytora Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06003530
Collaborator
(none)
22
Enrollment
1
Location
3
Arms
33.8
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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
  • Biological: hOMSC200
  • Other: Placebo
 Phase 1/Phase 2

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
Anticipated Enrollment :
22 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 treatmentPatients 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 :
Jan 6, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 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 [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 [24 weeks]

    Percentage of wound surface area reduction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Shaare Zedek Medical Center Jerusalem Israel 9103102

Sponsors and Collaborators

  • Cytora Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cytora Ltd.
ClinicalTrials.gov Identifier:
NCT06003530
Other Study ID Numbers:
  • Cyt DFU hOMSC200
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Feb 1, 2023
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

Study Results

No Results Posted as of Aug 22, 2023