PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
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ClinicalTrials.gov Identifier: NCT04104451 |
Recruitment Status :
Completed
First Posted : September 26, 2019
Last Update Posted : January 29, 2024
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Sponsor:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
Tracking Information | |||||
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First Submitted Date ICMJE | September 20, 2019 | ||||
First Posted Date ICMJE | September 26, 2019 | ||||
Last Update Posted Date | January 29, 2024 | ||||
Actual Study Start Date ICMJE | November 12, 2019 | ||||
Actual Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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®.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS | ||||
Official Title ICMJE | PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS | ||||
Brief 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). |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetic Foot Ulcer | ||||
Intervention ICMJE | Drug: Corlicyte
expanded umbilical cord lining mesenchymal stem cells
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE |
20 | ||||
Actual Study Completion Date ICMJE | August 1, 2023 | ||||
Actual Primary Completion Date | August 1, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion Criteria:
Exclusion Criteria: Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04104451 | ||||
Other Study ID Numbers ICMJE | 19-1113 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Colorado, Denver | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Colorado, Denver | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of Colorado, Denver | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |