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

NCT04104451 | Completed Phase 1 FDA Drug

• 1 other identifier: 19-1113
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• SAE

  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 Outcomes (7)

• Antibodies to HLA Class I - number and percent

  throughout study completion, an average of 4 months per subject

• Antibodies to HLA Class I - Time To Development

  throughout study completion, an average of 4 months per subject

• Increase Ulcer Size

  throughout study completion, an average of 4 months per subject

• Adverse Reaction

  throughout study completion, an average of 4 months per subject

• Suspected Adverse Reaction

  throughout study completion, an average of 4 months per subject

Study Arms (3)

Dose 1

EXPERIMENTAL

Drug: Corlicyte

Dose 2

EXPERIMENTAL

Drug: Corlicyte

Dose 3

EXPERIMENTAL

Drug: Corlicyte

Interventions

Corlicyte DRUG

expanded umbilical cord lining mesenchymal stem cells

Dose 1; Dose 2; Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Cecilia Low Wang, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 26, 2019
• Study Start: November 12, 2019
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)