- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04104451
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
January 26, 2024 updated by: University of Colorado, Denver
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 Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose 1
|
expanded umbilical cord lining mesenchymal stem cells
|
Experimental: Dose 2
|
expanded umbilical cord lining mesenchymal stem cells
|
Experimental: Dose 3
|
expanded umbilical cord lining mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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®.
|
throughout study completion, an average of 4 months per subject
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibodies to HLA Class I - number and percent
Time Frame: throughout study completion, an average of 4 months per subject
|
1. Number and percent of subjects who develop a high titer of antibodies to human leukocyte antigen (HLA) Class I molecules expressed on Corlicyte®
|
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
|
2. Time to development of high titer of antibodies to HLA Class I molecules expressed on Corlicyte®
|
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
|
3. 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).
|
throughout study completion, an average of 4 months per subject
|
Adverse Reaction
Time Frame: throughout study completion, an average of 4 months per subject
|
4. Number and percent of subjects with an adverse reaction to Corlicyte® in each cohort and overall.
|
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
|
5. Number and percent of subjects with a suspected adverse reaction to Corlicyte® in each cohort and overall.
|
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
|
6. Number and percent of subjects with a suspected serious adverse reaction to Corlicyte® in each cohort and overall.
|
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
|
7. Change in hemoglobin A1c from Screening to End-of-Study/Early Termination
|
throughout study completion, an average of 4 months per subject
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cecilia Low Wang, MD, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2019
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 26, 2019
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
-
National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan