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PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104451
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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).


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Corlicyte Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : May 2, 2021
Estimated Study Completion Date : August 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1 Drug: Corlicyte
expanded umbilical cord lining mesenchymal stem cells

Experimental: Dose 2 Drug: Corlicyte
expanded umbilical cord lining mesenchymal stem cells

Experimental: Dose 3 Drug: Corlicyte
expanded umbilical cord lining mesenchymal stem cells




Primary Outcome Measures :
  1. 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®.


Secondary Outcome Measures :
  1. 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®

  2. 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®

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria:

  1. Males or non-pregnant, non-lactating females.
  2. Age 18 or greater at the time of informed consent.
  3. Able and willing to provide written informed consent.
  4. Type 1 or Type 2 diabetes.
  5. Chronic DFU as the index ulcer meeting all of the following criteria:

    1. present for at least 4 weeks at the time of Screening Visit 1
    2. located below the malleoli of the foot
    3. extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule
    4. area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and
    5. non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1).
  6. 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.
  7. For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol.
  8. 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:

  1. 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.
  2. Women planning to become pregnant during the course of the study.
  3. 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.
  4. 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.
  5. Presence of actinic keratosis or skin cancer within 2 cm of the index ulcer.
  6. Cellulitis or other active infection of the index ulcer or any non-index ulcer at Screening.
  7. Use of an investigational agent for ulcer care within 30 days prior to Screening Visit 1.
  8. 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.
  9. Planned participation in another therapeutic study for any indication prior to completion of study participation.
  10. Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
  11. Known positivity for Human Immunodeficiency Virus (HIV).
  12. Active osteomyelitis or gangrene of either foot at Screening.
  13. Known Methicillin-resistant Staphylococcus aureus (MRSA) infection within 30 days prior to Screening Visit 1.
  14. Poorly-controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >12%.
  15. Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
  16. Planned use of cell therapy or amniotic membrane treatment for the index ulcer during study participation.
  17. Significant titer of antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads.
  18. Presence of severe peripheral artery disease (PAD) defined as clinical evidence of critical limb ischemia (CLI) during Screening.

Information from the National Library of Medicine

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): NCT04104451


Contacts
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Contact: Cecilia Low Wang, MD 303-724-7801 Cecilia.LowWang@CUAnschutz.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Nicola Haakonsen    720-848-2425      
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Cecilia Low Wang, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04104451    
Other Study ID Numbers: 19-1113
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases