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Trial registered on ANZCTR


Registration number
ACTRN12624000763549p
Ethics application status
Not yet submitted
Date submitted
3/06/2024
Date registered
21/06/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of patient-derived stem-cells (Rigenera autologous micrografts [AMT]) on surgical hair restoration outcomes in patient with hair loss undergoing Follicular Unit Transplant (FUT) hair transplant
Scientific title
A Randomised Controlled Trial Assessing the Efficacy of Intra-operative Rigenera Autologous Micrograft Therapy (AMT) on graft survival, hair follicle density and thickness in FUT Hair Transplant Patients vs placebo
Secondary ID [1] 312274 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenic alopecia 333994 0
Condition category
Condition code
Metabolic and Endocrine 330663 330663 0 0
Other endocrine disorders
Skin 330738 330738 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manufacturing of concentrated stem-cell solution from patient scalp tissue using Rigenera system. Stem-cell solution is then injected in to the recipient area immediately at the front of the scalp, where grafts have been implanted. One side of the scalp will receive the stem-cell solution in a grid pattern (0.2ml / cm^2) while a placebo will be injected on the contra lateral side.
“The Rigenera protocol”:
(i) collection of donor tissue from FUT strip - fat, tissue off-cuts and transected hair follicles all to be included
(ii) disaggregation of tissue using manufacturer's equipment "Rigeneracons" through the addition of 1 ml of sterile saline solution (performed by practice nurse)
(iii) collection of autologous micro-grafts obtained after the disaggregation and
(iv) injection of these micro-grafts (performed by the hair transplant doctor)
- 1ml syringe, injected into recipient area, 0.2ml / cm^2 in a grid pattern
- Depth 4mm using 30g needle
All the Rigenera AMT solution will be injected immediately after manufacture during the above procedure. The procedure will take around 30 mins and will be processing during the normal surgical time.
All remaining tissue used to create Rigenera AMT solution will be discarded in the same fashion as all other FUT off-cut tissue. No tissue is stored or recorded.
Adherence to the above protocol will be monitored by the hair transplant surgeon.
Intervention code [1] 328733 0
Treatment: Other
Comparator / control treatment
Placebo side of the recipient scalp will be injected with normal saline in a grid pattern as per the Rigenera side (0.2ml / cm^2)
Control group
Placebo

Outcomes
Primary outcome [1] 338411 0
Graft survival
Timepoint [1] 338411 0
We will take these readings at day 0 (pre-treatment), 2 weeks, 3 months, 6 months and 12 months (primary time point) post-treatment.
Primary outcome [2] 338412 0
Hair follicle density
Timepoint [2] 338412 0
Day 0 (pre-treatment), 2 weeks, 3 months, 6 months and 12 months (primary timepoint) post-treatment.
Primary outcome [3] 338413 0
Hair follicle thickness
Timepoint [3] 338413 0
Day 0 (pre-treatment), 2 weeks, 3 months, 6 months and 12 months (primary timepoint) post-treatment.
Secondary outcome [1] 435844 0
Patient satisfacton
Timepoint [1] 435844 0
Months 3, 6 and 12 post-treatment

Eligibility
Key inclusion criteria
Forty patients aged over 25 undergoing FUT hair transplant for androgenetic alopecia (AGA).
Patients selected based on their need for frontal region transplant
Frontal recipient area must have advanced AGA
Medications - Every patient should be stabilised on hair loss medications (ie slow progression or cessation of hair loss for >6 months using standard medical therapies)
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-androgenic cause for alopecia - autoimmune, scaring, thyroid, iron and vitamin D deficiencies.
Previous hair transplant surgery within past 18 months
Other regenerative treatments within past 12 months - Rigenera, Platelet rich plasma (PRP), Platelet rich fibrin (PRF)
Inter-current systemic illness or scalp disease - Human immunodeficiency virus (HIV), Hepatitis, cancer, haematological disease, fungal scalp, dermatitis
Interstate or out of area patients due to in-person follow up requirements - New South Wales (NSW) patients only

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Left side is allocated using a coin flip. Heads is treatment group and tails is placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316661 0
Commercial sector/Industry
Name [1] 316661 0
The Knudsen Clinic, Level 2, 45a Bay Street, Double Bay, Sydney 2028
Country [1] 316661 0
Australia
Funding source category [2] 316709 0
Commercial sector/Industry
Name [2] 316709 0
Mercato Medical, 108/114 Jonson Street, Byron Bay, 2481
Country [2] 316709 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Ellerby
Address
Country
Australia
Secondary sponsor category [1] 318846 0
Individual
Name [1] 318846 0
Dr Russell Knudsen
Address [1] 318846 0
Country [1] 318846 0
Australia
Secondary sponsor category [2] 318913 0
Commercial sector/Industry
Name [2] 318913 0
Mercato Medical, 108/114 Jonson Street, Byron Bay 2481
Address [2] 318913 0
Country [2] 318913 0
Australia
Other collaborator category [1] 283067 0
Individual
Name [1] 283067 0
Dr Sarah Macdonald
Address [1] 283067 0
Country [1] 283067 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315441 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315441 0
https://bellberry.com.au/
Ethics committee country [1] 315441 0
Australia
Date submitted for ethics approval [1] 315441 0
01/07/2024
Approval date [1] 315441 0
Ethics approval number [1] 315441 0

Summary
Brief summary
This study has been designed to assess the benefit of a stem-cell technology known as Rigenera Autologous Micrograft Therapy (AMT) in hair restoration.
Patient tissue is processed to produce a concentrated stem-cell solution which will be injected in to the scalp.
We are assessing if there is any improvement in FUT (Follicular Unit Transplant, aka “Strip surgery”) hair transplant surgery results when performed with Rigenera AMT during the operation.
We hypothesise that using Rigenera AMT solution in FUT surgery will improve graft survival and increase hair follicle thickness and density.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134706 0
Dr Adam Ellerby
Address 134706 0
The Knudsen Clinic, Level 2, 45a Bay Street, Double Bay, Sydney, NSW 2028
Country 134706 0
Australia
Phone 134706 0
+61 4 2673 0323
Fax 134706 0
Email 134706 0
[email protected]
Contact person for public queries
Name 134707 0
Deborah Krnak
Address 134707 0
The Knudsen Clinic, Level 2, 45a Bay Street, Double Bay, Sydney, NSW 2028
Country 134707 0
Australia
Phone 134707 0
+61 2 9327 0300
Fax 134707 0
Email 134707 0
[email protected]
Contact person for scientific queries
Name 134708 0
Dr Russell Knudsen
Address 134708 0
The Knudsen Clinic, Level 2, 45a Bay Street, Double Bay, Sydney NSW 2028
Country 134708 0
Australia
Phone 134708 0
+61 2 9327 0300
Fax 134708 0
Email 134708 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
Complexity of data collection and storage would make this process too complicated


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.