None listed
Conditions
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.
Interventions
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 fo
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.
Sponsors
Dr Adam Ellerby
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
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)
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
Outcome results
None listed