Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
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|ClinicalTrials.gov Identifier: NCT06003530|
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Diabetic Foot Ulcer Diabetic Foot Ulcer Neuropathic||Biological: hOMSC200 Other: Placebo||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|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)|
|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|
Experimental: Low dose hOMSC200
Administration of low dose hOMSC200 in addition to routine standard of care
Human Oral Mucosal Stem Cells
Experimental: High dose hOMSC200
Administration of high dose hOMSC200 in addition to routine standard of care
Human Oral Mucosal Stem Cells
Placebo Comparator: Placebo
Administration of placebo in addition to routine standard of care
Animal component-free, defined cryopreservation medium with 5% DMSO
- 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.
- Wound healing [ Time Frame: 24 weeks ]Percentage of wound surface area reduction
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 ClinicalTrials.gov identifier (NCT number): NCT06003530
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 9103102|
|Contact: Matitiau Z Noff, MD 972-52-2550505 firstname.lastname@example.org|
|Principal Investigator: Matitiau Z Noff, MD|