Could amniotic fluid injections regrow hair? new trial begins

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, aged 18 to 70 years (inclusive) at the time of informed consent * Able to understand and voluntarily provide written informed consent * Willing and able to comply with study procedures, including all scheduled visits and assessments * In good general health as determined by the Investigator based on medical history and screening assessments * Clinical diagnosis of androgenetic alopecia (AGA) with documented hair loss for at least 6 months prior to screening * Stable pattern of hair loss (no rapid progression) for at least 6 months prior to screening * Male subjects: Norwood-Hamilton Classification Stage III, IIIa, IIIv, IV, or IVa * Female subjects: Ludwig Classification Stage I or II * Normal thyroid function (TSH within normal limits) at screening, or stable on thyroid replacement therapy for at least 6 months * Ferritin level within normal limits at screening, or documented adequate iron stores * No clinically significant abnormalities on CBC with differential or comprehensive metabolic panel (CMP) at screening outside protocol-defined eligibility thresholds * Female subjects of childbearing potential must have a negative urine pregnancy test at screening and agree to use an effective method of contraception throughout the study and for 30 days after the last treatment * Female subjects who are postmenopausal (no menses for at least 12 months) or surgically sterile are not required to use contraception Exclusion Criteria: * Use of topical or oral minoxidil within 3 months prior to screening * Use of oral finasteride or dutasteride within 6 months prior to screening * Use of topical finasteride within 3 months prior to screening * Platelet-rich plasma (PRP), exosome, or other regenerative scalp injections within 6 months prior to screening * Hair transplant surgery within 12 months prior to screening * Low-level laser therapy (LLLT) or other light-based hair treatments within 3 months prior to screening * Scalp microneedling within 3 months prior to screening * Use of drugs with anti-androgenic properties (e.g., spironolactone, cyproterone acetate, flutamide) within 6 months prior to screening * Systemic corticosteroids within 2 weeks prior to screening, or corticosteroid scalp injections within 1 month prior to screening * Chronic daily NSAID use (defined as daily use for 14 or more consecutive days), other than low-dose aspirin (81 mg/day or less) for cardiovascular prophylaxis * Diagnosis or history of alopecia areata, cicatricial (scarring) alopecia, telogen effluvium, traction alopecia, or other non-AGA hair loss conditions * Norwood-Hamilton Stage V, VI, or VII (male subjects); Ludwig Stage III (female subjects) * Active or history of malignancy within 5 years prior to screening, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix * Known or suspected autoimmune disease (e.g., lupus, rheumatoid arthritis, psoriasis with scalp involvement) * Known or newly identified immunodeficiency or immunocompromised state, including HIV infection identified at screening * Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) at screening * Platelet count less than 100,000/µL, bleeding disorder, or hemoglobin less than 10 g/dL at screening * Current use of anticoagulant therapy (e.g., warfarin, heparin, direct oral anticoagulants), P2Y12 receptor inhibitors (e.g., clopidogrel, prasugrel, ticagrelor), phosphodiesterase inhibitor antiplatelet agents (e.g., cilostazol, dipyridamole), or dual antiplatelet therapy * Uncontrolled thyroid disease or thyroid dysfunction not adequately managed on stable therapy * Uncontrolled diabetes (HbA1c greater than 9%) or other significant metabolic disorder * Active scalp infection, inflammation, or dermatological condition in the treatment area * Open wounds, abrasions, or abnormalities on the scalp in the intended treatment area * History of keloid formation or propensity for keloids * Hair weaving or use of hair pieces that cannot be removed for study assessments * Known hypersensitivity or allergy to any component of XVIE or human-derived biological products * Known allergy to lidocaine or other local anesthetics * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period * Positive urine pregnancy test at screening or Day 0 * Participation in another interventional clinical trial within 30 days prior to screening or concurrent participation in another clinical study * History of drug or alcohol abuse within 12 months prior to screening * Use of systemic immunosuppressive therapy within 5 half-lives or 30 days prior to screening, whichever is longer, including biologic agents, conventional DMARDs, JAK inhibitors, and calcineurin inhibitors * Use of topical JAK inhibitors applied to the scalp within 30 days prior to screening * Any condition that, in the Investigator's judgment, would make the subject unsuitable for study participation