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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05165628




Registration number
NCT05165628
Ethics application status
Date submitted
18/10/2021
Date registered
21/12/2021
Date last updated
24/05/2024

Titles & IDs
Public title
Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers
Scientific title
A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers
Secondary ID [1] 0 0
CYP-DFU-P1-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcer 0 0
Cutaneous Ulcer 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Skin 0 0 0 0
Other skin conditions
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CYP-006TK

Experimental: Group 1 - CYP-006TK - Participants will receive CYP-006TK dressings

No intervention: Group 2 - Standard of Care - Participants will continue to be treated as per local standard of care


Other interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
Incidence of changes from baseline in haematology, biochemistry, and urinalysis parameters.
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
Percentage of area change of study ulcer from baseline to weeks 12 and 24
Timepoint [1] 0 0
12 and 24 weeks
Secondary outcome [2] 0 0
Number of days to complete ulcer healing
Timepoint [2] 0 0
12 and 24 weeks
Secondary outcome [3] 0 0
Number of days to 50% ulcer healing
Timepoint [3] 0 0
12 and 24 weeks
Secondary outcome [4] 0 0
Percentage change in ulcer volume from baseline to weeks 12 and 24
Timepoint [4] 0 0
12 and 24 weeks
Secondary outcome [5] 0 0
Changes from baseline in ulcer pain assessed using a Numeric Rating Scale
Timepoint [5] 0 0
12 and 24 weeks
Secondary outcome [6] 0 0
Number clinic/home care visits across groups
Timepoint [6] 0 0
12 and 24 weeks
Secondary outcome [7] 0 0
Differences across groups on ulcer dressing products used
Timepoint [7] 0 0
12 and 24 weeks
Secondary outcome [8] 0 0
Changes from baseline in Quality of Life assessed using the Cardiff Wound Impact Schedule
Timepoint [8] 0 0
12 and 24 weeks
Secondary outcome [9] 0 0
Duration of clinic/home care visits across groups
Timepoint [9] 0 0
12 and 24 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Central Adelaide Local Health Network - Adelaide
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cynata Therapeutics Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05165628
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jolanta Airey, MD
Address 0 0
Cynata Therapeutics Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05165628