Diabetic Foot UlcerPhase 1NCT04104451
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
A Phase 1 study testing Corlicyte in people with Diabetic Foot Ulcer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Corlicyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 1 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-lactating females.
- Age 18 or greater at the time of informed consent.
- Able and willing to provide written informed consent.
- Type 1 or Type 2 diabetes.
- Chronic DFU as the index ulcer meeting all of the following criteria:
- present for at least 4 weeks at the time of Screening Visit 1
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- located below the malleoli of the foot
- extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule
- area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and
- non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1).
- Negative for antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads, within 3 months prior to start of Treatment Phase without interval sensitizing events.
- For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol.
- In women of childbearing potential, willingness to use effective means of birth control during the course of the study; if using systemic birth control, this must have been used for 6 months or longer prior to Screening Visit 1.
Who cannot join
- Planned DFU treatment to the index ulcer that includes enzymatic agents, cytotoxic agents or any substance(s) that would affect MSC survival during the study period.
- Women planning to become pregnant during the course of the study.
- Significant history of, or current evidence of a severe comorbid medical or psychiatric condition such as liver disease, end-stage renal disease, untreated proliferative retinopathy, bleeding diathesis, schizophrenia, or laboratory abnormality that, in the opinion of the Investigator, would preclude enrollment because of unacceptable risk.
- Presence of any skin condition or skin disorder around the index ulcer that might interfere with the diagnosis of or assessment of study-related endpoints, such as atopic dermatitis, eczema, psoriasis, or seborrheic dermatitis.
- Presence of actinic keratosis or skin cancer within 2 cm of the index ulcer.
- Cellulitis or other active infection of the index ulcer or any non-index ulcer at Screening.
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- Use of an investigational agent for ulcer care within 30 days prior to Screening Visit 1.
- Receipt of an investigational agent or device not approved by the US FDA for marketed use in any indication within 30 days prior to Screening Visit 1.
- Planned participation in another therapeutic study for any indication prior to completion of study participation.
- Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
- Known positivity for Human Immunodeficiency Virus (HIV).
- Active osteomyelitis or gangrene of either foot at Screening.
- Known Methicillin-resistant Staphylococcus aureus (MRSA) infection within 30 days prior to Screening Visit 1.
- Poorly-controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >12%.
- Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
- Planned use of cell therapy or amniotic membrane treatment for the index ulcer during study participation.
- Significant titer of antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads.
- Presence of severe peripheral artery disease (PAD) defined as clinical evidence of critical limb ischemia (CLI) during Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Study Objective:
The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Corlicyte
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorlicyteDrug
expanded umbilical cord lining mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: Corlicyte |
| Dose 2 | Experimental | Not described Receives: Drug: Corlicyte |
| Dose 3 | Experimental | Not described Receives: Drug: Corlicyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE
Number and percent of subjects in each dosing cohort and overall with a serious adverse reaction to Corlicyte®.
Measured: throughout study completion, an average of 4 months per subject
Secondary outcomes (7)
Antibodies to HLA Class I - number and percent
- Number and percent of subjects who develop a high titer of antibodies to human leukocyte antigen (HLA) Class I molecules expressed on Corlicyte®
Measured: throughout study completion, an average of 4 months per subject
Antibodies to HLA Class I - Time To Development
- Time to development of high titer of antibodies to HLA Class I molecules expressed on Corlicyte®
Measured: throughout study completion, an average of 4 months per subject
Increase Ulcer Size
- Number and percent of subjects with an increase in ulcer size by the end of the Treatment Phase as reviewed by the Wound Core Laboratory (WCL).
Measured: throughout study completion, an average of 4 months per subject
Adverse Reaction
- Number and percent of subjects with an adverse reaction to Corlicyte® in each cohort and overall.
Measured: throughout study completion, an average of 4 months per subject
Suspected Adverse Reaction
- Number and percent of subjects with a suspected adverse reaction to Corlicyte® in each cohort and overall.
Measured: throughout study completion, an average of 4 months per subject
Suspected Serious Adverse Reaction
- Number and percent of subjects with a suspected serious adverse reaction to Corlicyte® in each cohort and overall.
Measured: throughout study completion, an average of 4 months per subject
Change in A1c
- Change in hemoglobin A1c from Screening to End-of-Study/Early Termination
Measured: throughout study completion, an average of 4 months per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start12 Nov 2019
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Low Wang, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104451
- Sponsor's protocol ID
- 19-1113
- Status last verified
- Jan 2024
- First submitted
- 20 Sep 2019
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
- ClinicalTrials.gov ID
- NCT04104451
- Acronym / sponsor ID
- 19-1113
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 Sep 2019 (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.
Study Objective:
The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: Corlicyte |
| Dose 2 | Experimental | Drug: Corlicyte |
| Dose 3 | Experimental | Drug: Corlicyte |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or non-pregnant, non-lactating females.
- Age 18 or greater at the time of informed consent.
- Able and willing to provide written informed consent.
- Type 1 or Type 2 diabetes.
- Chronic DFU as the index ulcer meeting all of the following criteria:
Key exclusion criteria (18 listed)
- Planned DFU treatment to the index ulcer that includes enzymatic agents, cytotoxic agents or any substance(s) that would affect MSC survival during the study period.
- Women planning to become pregnant during the course of the study.
- Significant history of, or current evidence of a severe comorbid medical or psychiatric condition such as liver disease, end-stage renal disease, untreated proliferative retinopathy, bleeding diathesis, schizophrenia, or laboratory abnormality that, in the opinion of the Investigator, would preclude enrollment because of unacceptable risk.
- Presence of any skin condition or skin disorder around the index ulcer that might interfere with the diagnosis of or assessment of study-related endpoints, such as atopic dermatitis, eczema, psoriasis, or seborrheic dermatitis.
- Presence of actinic keratosis or skin cancer within 2 cm of the index ulcer.
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 |
|---|---|---|
| Corlicyteexpanded umbilical cord lining mesenchymal stem cells | Drug | Dose 1, Dose 2, Dose 3 |
Primary outcome
SAE
Time frame: throughout study completion, an average of 4 months per subject
Number and percent of subjects in each dosing cohort and overall with a serious adverse reaction to Corlicyte®.
7 secondary outcomes
Antibodies to HLA Class I - number and percent
Time frame: throughout study completion, an average of 4 months per subject
Antibodies to HLA Class I - Time To Development
Time frame: throughout study completion, an average of 4 months per subject
Increase Ulcer Size
Time frame: throughout study completion, an average of 4 months per subject
Adverse Reaction
Time frame: throughout study completion, an average of 4 months per subject
Suspected Adverse Reaction
Time frame: throughout study completion, an average of 4 months per subject
Suspected Serious Adverse Reaction
Time frame: throughout study completion, an average of 4 months per subject
Change in A1c
Time frame: throughout study completion, an average of 4 months per subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Cecilia Low Wang, MD principal investigator
University of Colorado, Denver
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 Corlicyte in people with Diabetic Foot Ulcer, run by University of Colorado, Denver at 1 site in United States.
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 13 inclusion and 18 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: finished, as of the sponsor's last update on 29 Jan 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SAE (time frame: throughout study completion, an average of 4 months per subject). 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 29 Jan 2024.