Androgenetic Alopecia - Male Pattern Baldness.
Conditions
Interventions
Product Name: ICX-TRC
Product Code: ICX-TRC
Pharmaceutical Form: Suspension for injection
Other descriptive name: Human Dermal Papilla Cells
Sponsors
Intercytex
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males aged 18-60 years, who are ambulatory and, in the opinion of the investigator, in good general physical and mental health. Individuals with androgenetic alopecia characterised as male pattern baldness using the Norwood - Hamilton scale stage IV to VII. Individuals who are willing and able to supply a sample of scalp tissue containing greater than 120 hair follicles (0.5cm2 - 2cm2 strip of tissue). Individuals willing to participate in the study and follow its requirements. Individuals able to give informed voluntary consent and able to estimate own risks and benefits of participation. Individuals, who are, in the opinion of the investigator, able to understand this study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals who do not have MPB. Individuals younger than 18 years of age. Individuals with abnormal blood biochemistry defined as three times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant. Individuals who have received anticoagulant medication, including Warfarin, within 7 days of screening. Individuals who participated in this or another study with any investigational drug or device within the past 28 days. Individuals with intended hair transplant in the target treatment area during the study duration. Individuals with recent transplant in the area to be treated with ICX-TRC. Individuals with life expectancy of less than 9 months, terminal conditions or factors making follow-up difficult (no fixed address, telephone etc.). Individuals who have begun a course of finasteride or minoxidal in the last year. (Subjects currently using these compounds who have been using them continuously for at least a year are eligible) Individuals who intend to have a major surgical intervention within 6 months of enrolment in the study. Individuals with a history of any illness or condition that, in the opinion of the investigator, might mask the results of the study and/or pose additional risk to the individual e.g. uncontrolled thyroid condition or type I/II diabetes mellitus, uncontrolled hypertension, bleeding disorders, autoimmune disorders, long term steroid use, scalp clinical infection, other skin conditions: severe scarring alopecia, infection, inflammation (e.g. seborrhoeic dermatitis). Individuals with, or with suspected, malignancy. Individuals with sensitivity to HypoThermosol-FRS®. Individuals with a know hypersensitivity to, or a religious or ethical objection to, bovine or porcine products. Individuals who have a known transmissible disease. Individuals with intolerance to compounds used in this protocol (Chlorhexidine wash, Isopropropyl Alcohol, Diazepam, Saline Tumescent Solution, Adrenaline, Lignocaine, Coproxamol). Individuals who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. Individuals previously enrolled and treated in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of ICX-TRC in androgenetic alopecia;Secondary Objective: Safety analysis and efficacy up to 48 weeks post treatment; Primary end point(s): Hair growth at 6, 12, 24, 36 and 48 weeks as determined by the investigator. | — |
Countries
United Kingdom
Outcome results
None listed