Diabetic FootPhase 1NCT06003530
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
A Phase 1 study testing hOMSC200 in people with Diabetic Foot and Diabetic Foot Ulcer, run by Cytora Ltd. at 1 site in Israel.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- What is being tested?
- hOMSC200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Jan 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200
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).
Read the 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.
- Being tested
- hOMSC200, Placebo
- Keywords
- diabetic foot ulcer, stem cells
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hOMSC200Biological
Human Oral Mucosal Stem Cells
PlaceboOther
Animal component-free, defined cryopreservation medium with 5% DMSO
| Study group | Role | What they receive |
|---|---|---|
| Low dose hOMSC200 | Experimental | Administration of low dose hOMSC200 in addition to routine standard of care Receives: Biological: hOMSC200 |
| High dose hOMSC200 | Experimental | Administration of high dose hOMSC200 in addition to routine standard of care Receives: Biological: hOMSC200 |
| Placebo | Placebo comparator | Administration of placebo in addition to routine standard of care Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Wound healing
Percentage of wound surface area reduction
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start6 Jan 2022
- Primary completion19 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytora Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003530
- Sponsor's protocol ID
- Cyt DFU hOMSC200
- Status last verified
- Mar 2024
- First submitted
- 15 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Study for Treatment of Chronic Diabetic Foot Ulcers (DFU) With the Investigational Allogeneic Cell Therapy Product, hOMSC200
- ClinicalTrials.gov ID
- NCT06003530
- Acronym / sponsor ID
- Cyt DFU hOMSC200
- Keywords
- diabetic foot ulcer, stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cytora Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Low dose hOMSC200 | Experimental | Biological: hOMSC200Administration of low dose hOMSC200 in addition to routine standard of care |
| High dose hOMSC200 | Experimental | Biological: hOMSC200Administration of high dose hOMSC200 in addition to routine standard of care |
| Placebo | Placebo comparator | Other: PlaceboAdministration of placebo in addition to routine standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hOMSC200Human Oral Mucosal Stem Cells | Biological | High dose hOMSC200, Low dose hOMSC200 |
| PlaceboAnimal component-free, defined cryopreservation medium with 5% DMSO | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Wound healing
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hOMSC200 in people with Diabetic Foot and Diabetic Foot Ulcer, run by Cytora Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.