Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers

A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers

Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers.

The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups:

• Group 1: CYP-006TK
• Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation.

Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study.

Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Cutaneous Ulcer
• Intervention / Treatment: Combination product: CYP-006TK

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Central Adelaide Local Health Network
  • Western Australia
    • Perth, Western Australia, Australia
      • Sir Charles Gairdner Hospital
    • Perth, Western Australia, Australia
      • Royal Perth Hospital
    • Perth, Western Australia, Australia
      • Fiona Stanley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults at least 18 years of age up to 80 years of age, inclusive.
2. Have a current diagnosis of diabetes mellitus (DM)
3. With at least one non-healing cutaneous ulcer on the foot or the lower legs
4. With ankle brachial index (ABI) ≥ 0.4 and/or toe pressure >30 mmHg on the limb with the study ulcer.
5. Participant co-morbidities are adequately managed, and the participant has a life expectancy of at least 6 months as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
6. A negative pregnancy test, (i.e. for female participants with childbearing potential).
7. Willing to comply with birth control measures, to prevent female participants becoming pregnant for six months following administration of the study treatment.
8. Able to follow the Investigator's instruction on ulcer care (in the opinion of the Investigator).
9. Agrees to provide written informed consent.

Exclusion Criteria:

1. Planned vascular surgery, angioplasty, thrombolysis or amputation of the affected limb in the next six months.
2. Pregnant or breastfeeding.
3. Active infection in the study ulcer.
4. Any sign of osteomyelitis associated with the study ulcer.
5. Study ulcer extends to bone or periosteum (ulcers that reach a ligament, joint capsule, fascia, or tendon are not excluded).
6. Study ulcer requires daily dressing changes.
7. Known autoimmune disease other than diabetes, including but not limited to lupus erythematosus, multiple sclerosis which are considered as clinically significant by PI and/or Medical Monitor.
8. Treatment with systemic immunosuppressants within 90 days of screening.
9. Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
10. Serum GGT, AST or ALT > 5 × upper limit of the normal range (ULN).
11. . Known history of HIV infection
12. Prior administration of any cell-based treatment to the limb affected by the study ulcer.
13. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned initiation of study treatment.
14. Any other medical condition or laboratory abnormality judged as clinically significant by the Investigator or study Medical Monitor which could confound the evaluation of the trial treatment.
15. With history of sensitivity to materials of bovine, porcine origin, or human serum albumin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - CYP-006TK; Participants will receive CYP-006TK dressings	Combination product: CYP-006TK; CYP-006TK is allogenic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs) or Cymerus™ MSCs, seeded onto a heptylamine plasma polymer-coated silicone dressing
No Intervention: Group 2 - Standard of Care; Participants will continue to be treated as per local standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)		24 weeks
Incidence of changes from baseline in haematology, biochemistry, and urinalysis parameters.	Results will be summarised by individual and by treatment group using descriptive statistics.	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of area change of study ulcer from baseline to weeks 12 and 24	12 and 24 weeks
Number of days to complete ulcer healing	12 and 24 weeks
Number of days to 50% ulcer healing	12 and 24 weeks
Percentage change in ulcer volume from baseline to weeks 12 and 24	12 and 24 weeks
Changes from baseline in ulcer pain assessed using a Numeric Rating Scale	12 and 24 weeks
Number clinic/home care visits across groups	12 and 24 weeks
Differences across groups on ulcer dressing products used	12 and 24 weeks
Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule	12 and 24 weeks
Duration of clinic/home care visits across groups	12 and 24 weeks

Collaborators and Investigators

• Sponsor: Cynata Therapeutics Limited
• Investigators: Study Director: Jolanta Airey, MD, Cynata Therapeutics Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer; Skin Ulcer
• Other Study ID Numbers: CYP-DFU-P1-01

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No