search
Back to results

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

Primary Purpose

Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic

Status
Recruiting
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
hOMSC200
Placebo
Sponsored by
Cytora Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring diabetic foot ulcer, stem cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shaare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose hOMSC200

High dose hOMSC200

Placebo

Arm Description

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

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

Administration of placebo in addition to routine standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Wound healing
Percentage of wound surface area reduction

Full Information

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Cytora Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06003530
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytora Ltd.

4. Oversight

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

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
Keywords
diabetic foot ulcer, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose hOMSC200
Arm Type
Experimental
Arm Description
Administration of low dose hOMSC200 in addition to routine standard of care
Arm Title
High dose hOMSC200
Arm Type
Experimental
Arm Description
Administration of high dose hOMSC200 in addition to routine standard of care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of placebo in addition to routine standard of care
Intervention Type
Biological
Intervention Name(s)
hOMSC200
Intervention Description
Human Oral Mucosal Stem Cells
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Animal component-free, defined cryopreservation medium with 5% DMSO
Primary Outcome Measure Information:
Title
Treatment related adverse events
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wound healing
Description
Percentage of wound surface area reduction
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matitiau Z Noff, MD
Phone
972-52-2550505
Email
mnoff@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Matitiau Z Noff, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs