Safety and Efficacy of HST 001 in Male Pattern Hair Loss

• Single center, randomized, controlled, parallel-design study in participants with mild to moderate hair loss on a Norwood-Hamilton (N-H) Scale
• Double-blind: Evaluating Investigator (EI) and participants are blinded; Treating Investigator (TI) is not blinded
• Investigational product is randomly assigned to subjects upon enrollment and will receive either HST 001 or placebo (phosphate buffered saline [PBS]). Injections will be delivered via 1 mL syringes with 31 Gauge needles to the target depth of 1.75 mm, using a slow injection technique and holding the needle in position for count of 3-4 seconds. Each injection will provide 0.1 mL and a total of 20 injections will be given in the scalp with particular attention to the leading edge of the vertex and the temporal recession areas
• Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another. Dosing will be split between the leading edge of the vertex region (~10 injections covering 10.18 cm2) and in each temporal recession area (~5 injections covering 7.07cm2) in each.
• Adverse Events (AEs) will be monitored to ensure safety of participants throughout the study
• Efficacy will be assessed at Week 18 and Week 26 via macrophotography and TAHC by the Canfield HairMetrix System

Inclusion criteria

• Must be 25 to 55 years of age inclusive, at the time of signing the informed consent
• Should be in good general health with a healthy scalp with no cutaneous disorder determined by medical history or physical examination
• Are classified as III Vertex (3 Vertex), IV (4) and V (5) under the N H Classification for male pattern hair loss (MPHL). Subjects should have some thinning in both the vertex and temporal regions of the scalp
• Willing to maintain the same hair-style during the study period. No razor shaving of head (bald) prior to study start and throughout the study period
• Must be Male.
• Willing to have two dot tattoos of the scalp
• Willing to have an approximately 1.0 cm2 area of hairs clipped in the vertex region and 0.5 cm2 in one temporal recession area at each visit where macrophotography is conducted
• Willing to comply with scheduled 7 visits in 26 weeks (or screening in + 6 = 7 visits)
• Willing to continue normal hair care shampoo throughout the course of the study
• Willing to maintain the same hair care routine and forgo the use of new scalp products, throughout the study
• Willing to undergo routine venipuncture for safety laboratory testing as well as a blood spot test for Vitamin D level analysis
• Capable of giving informed consent
• Fluent and literate in English
• Able to follow instructions and likely to complete all study visits as assessed by investigator and staff

Exclusion criteria

• History of keloid formation or significant hyperpigmentation
• History of other forms of hair loss - Alopecia areata, trichotillomania, scarring alopecia etc.
• History of acute or chronic illness that in the opinion of the investigator might confound the results of the study including some drug medications
• Active skin diseases (eczema, atopic dermatitis, psoriasis, skin cancer, sun-damaged skin with actinic keratosis on the scalp, etc.) in or around the area to be treated
• Routine use of prescription anti inflammatory medications, immunosuppressive drugs, or antihistamine medications
• Use of topical drugs or other cosmetics on the scalp
• Use of over the counter (OTC) or prescriptive topical hair treatments, including hair transplantation during the last 6 months
• Currently using a hair system or wig
• History of hair transplants or scalp reduction surgery
• History of allergy or intolerance to lidocaine and/or epinephrine
• Use of hair dye within 3 days of the treatments, otherwise, willing to maintain the same hair color for the study duration
• Current enrollment in an investigational drug or device study
• Has tattoos or scars in scalp that would interfere with visual assessment
• Is an employee of the investigator's site, and employee or representative of Histogen, investor, or a relative with one of the above
• Has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's involvement in the study
• Known allergy to rice
• Known allergy to bovine products