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Trial registered on ANZCTR


Registration number
ACTRN12620000944932
Ethics application status
Approved
Date submitted
20/08/2020
Date registered
22/09/2020
Date last updated
26/03/2021
Date data sharing statement initially provided
22/09/2020
Date results information initially provided
26/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I study to assess the safety of a human non-autologous platelet derived Extracellular Vesicle therapy in wound healing
Scientific title
A prospective, Randomised, Double Blind, Placebo Controlled, single dose, single site phase I study to assess the safety and biological activity of a Human non-autologous platelet derived Extracellular Vesicle therapy vs placebo on wound healing rate following skin punch biopsy in healthy volunteer adults
Secondary ID [1] 301594 0
None
Universal Trial Number (UTN)
Trial acronym
PLEXOVAL II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous wound healing 317979 0
Condition category
Condition code
Skin 316012 316012 0 0
Normal skin development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention 'PLEXARIS OS' is a non-autologous, human donor platelet derived Extracellular Vesicle product. The platelets used to derive the Extracellular Vesicles are sourced from Australian blood donors.

Each participant receives a bilateral 4mm punch biopsy induced wound to their upper inner arms. The Product dose of 0.3 mg/mL is administered by subcutaneous injection to one of the two punch biopsy induced wounds of each participant. The Placebo is identically administered to the other punch biopsy induced wound of the participant as a comparator.

Both the product and placebo are a single dose administration performed at Day 0 and each participant is monitored by follow-up to 30 days post administration. The subcutaneous injection is administered by the Principal Investigator or delegate (qualified physicians) both of who are blinded to the product and placebo. The participant is blinded to the administration of the product and placebo. The wound is assessed at each follow up visit by a qualified dermatologist who is blinded to the wounds that received the product and placebo. The intervention is assessed in all participants to 30 days with follow up at Days 3, 7, 14 and 30.

The participant consent form (PICF) contains details of the product source and its composition, the risks associated with the source material used for the product, what is involved in the study, how product is administered, how the punch biopsy is performed, blood samples taken for lab tests, schedule of required follow up visits and what is expected of the participant to adhere to the study.

The health status of each participant will be assessed at each follow up visit by performing a physical examination and assessing their vital signs (Blood Pressure, Respiratory Rate, Body Temperature and Pulse Rate). A blood sample will also be taken at each follow up visit to assess haematological (FBE & clotting factors) and biochemical characteristics (LFT, KFT, etc) and monitor for any change in baseline results.
Intervention code [1] 317901 0
Treatment: Drugs
Comparator / control treatment
Placebo, made up of the same formulation as the Product but not containing the drug API, subcutaneously administered identically to the Product to the punch biopsy induced wound site of the other arm.. i.e. not the arm where the Product was administered
Control group
Placebo

Outcomes
Primary outcome [1] 324216 0
Incidence and severity of adverse events considered to be related to the treatment.

AEs are considered any untoward medical occurrence or unintended sign including an abnormal lab test, symptom or disease condition, exacerbation of pre-existing conditions, and any life threatening effect or requirement for hospitalisation. Each participant is assessed for vital signs at each follow up visit and a blood sample taken to determine any change in baseline haematological (FBE & clotting factors) and biochemical (LFT, KFT, creatinine, albumin, etc) test results.

All AEs and SAEs are recorded and reported in accordance with the Grade of Intensity to the DSMB. The PI is responsible for following up all AEs and SAEs until resolved.
Timepoint [1] 324216 0
Day 0, 3, 7, 14 & 30 post administration of intervention.
Secondary outcome [1] 384092 0
Determination of time to wound healing between the product treated wound compared to the placebo treated control wound at scheduled follow up visits to completion.

Each participant's wound will be assessed for scar formation, evidence of erythema, induration, exudate, infection, fibrin coverage and granulation. The diameter of each wound will be measured using a measurement gauge ( calibrated calipers) to determine the rate of healing followed by physical assessment by the Dermatologist of the wound using the Modified Hollander Wound Evaluation Scale (MHWES) commonly used in wound assessment. The MHWES consists of assessing contour irregularity, margin separation, edge inversion, excessive distortion, presence of step off of border and overall wound healing appearance. The MHWES data and all study data s recorded in an eCRF. Results of lab tests will be recorded in the eCRF and the participant informed of any abnormal results.
Timepoint [1] 384092 0
Day 3, 7, 14 & 30 post administration of intervention..

Eligibility
Key inclusion criteria
Healthy adults aged 18 to 64 years of age
Able to read, understand and sign Participant Information and Consent Form
Eligible for punch biopsy
Suitable health status to participate in the study, determined by medical history, vital signs, physical examination and within acceptable test range for general haematological laboratory profiles and general biochemistry laboratory profiles for metabolism & hormones
No history of diabetes or cardiac disease (e.g. hypertension, arrhythmia, etc) which can impede and delay wound healing.
No history of any bleeding or coagulation disorders.
No history of malignancy, except for fully excised Squamous Cell Carcinoma and Basal Cell Carcinoma.
No active or chronic diseases/disorders requiring systemic treatment, no history of hospitalisation for illness within the six months prior to enrolment into study, and no major surgery within the 6 months prior to enrolment into study
Females of child-bearing potential must be non-pregnant, (as confirmed by ß-HCG serum test at screening visit and urine test at dosing visit 1) and non-lactating.
All females of childbearing potential, and male participants with female partners of child-bearing potential, must agree to take medically acceptable contraception measures whilst on the treatment and for 30 days following treatment.
Agree to maintain wound dressings as per study instructions
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Existing scars in study area or evidence of infection;
Evidence of existing chronic dermatological conditions such as psoriasis and eczema.
Participation in another clinical study or prior participation within 3 months of first visit;
History of any clinically important severe allergic or anaphylactic reaction or known or suspected hypersensitivity to compounds similar to the investigational product;
History of clinically important or uncontrolled systemic disease or condition as determined by the investigator;
Concurrent administration of NSAIDs, Immunosuppressive agents, anticoagulation therapy including low dose aspirin or systemic corticosteroids therapy.

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
First in Human Safety Study. Not powered. Analysis based on Wound Healing Rate and descriptive statistics for demographic details (Age, Gender, Race, Ethnicity), baseline vital sign measurements (BT, BP, PR & RR) and recorded AEs,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2020
Actual
22/09/2020
Date of last participant enrolment
Anticipated
16/10/2020
Actual
15/12/2020
Date of last data collection
Anticipated
4/12/2020
Actual
15/01/2021
Sample size
Target
10
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16962 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 30622 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 306026 0
Commercial sector/Industry
Name [1] 306026 0
Exopharm Ltd
Country [1] 306026 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Exopharm ltd
Address
Level 17/31 Queen Street, Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 306485 0
None
Name [1] 306485 0
Address [1] 306485 0
Country [1] 306485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306256 0
Bellberry Limited
Ethics committee address [1] 306256 0
123 Glen Osmond Road, Eastwood South Australia 5063
Ethics committee country [1] 306256 0
Australia
Date submitted for ethics approval [1] 306256 0
08/07/2020
Approval date [1] 306256 0
20/08/2020
Ethics approval number [1] 306256 0

Summary
Brief summary
A Placebo controlled Phase I study to demonstrate the safety of a therapy using nano vesicles purified from human donor platelets and administered to healthy adult volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103258 0
Prof Stephen Hall
Address 103258 0
Emeritus Research Pty Ltd, Level 2, 1180 Toorak Road, Camberwell, Victoria Australia 3124
Country 103258 0
Australia
Phone 103258 0
+61 03 95096166
Fax 103258 0
Email 103258 0
[email protected]
Contact person for public queries
Name 103259 0
Teresa Ringeri
Address 103259 0
Emeritus Research Pty Ltd, Level 2, 1180 Toorak Road, Camberwell, Victoria Australia 3124
Country 103259 0
Australia
Phone 103259 0
+61 03 95096166
Fax 103259 0
Email 103259 0
[email protected]
Contact person for scientific queries
Name 103260 0
Ivan Jasenko
Address 103260 0
Exopharm Ltd, Level 17/31 Queen Street, Melbourne, Victoria Australia 3000
Country 103260 0
Australia
Phone 103260 0
+61 401359111
Fax 103260 0
Email 103260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is proprietary to Exopharm Ltd and will remain strictly confidential.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo This phase I study of the nano vesicle product (Pl... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFirst-in-human clinical trial of allogeneic, platelet-derived extracellular vesicles as a potential therapeutic for delayed wound healing.2023https://dx.doi.org/10.1002/jev2.12332
N.B. These documents automatically identified may not have been verified by the study sponsor.