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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06003530
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
Information provided by (Responsible Party):
Cytora Ltd.

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
Diabetic Foot Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : January 6, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Wound healing [ Time Frame: 24 weeks ]
    Percentage of wound surface area reduction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT06003530

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Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Matitiau Z Noff, MD    972-52-2550505   
Principal Investigator: Matitiau Z Noff, MD         
Sponsors and Collaborators
Cytora Ltd.
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Responsible Party: Cytora Ltd. Identifier: NCT06003530    
Other Study ID Numbers: Cyt DFU hOMSC200
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: February 2023

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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:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases