BACKGROUND:Adipose and adipose derived regenerative cells (ADRCs) play an increasing role in androgenetic alopecia. OBJECTIVES:The authors sought to evaluate the safety and feasibility of fat grafts enriched with ADRCs in early androgenetic alopecia. METHODS:Seventy-one patients were treated: 16 with Puregraft fat and 1.0 × 106 ADRCs/cm2 scalp; 22 with Puregraft fat and 0.5 × 106 ADRCs/cm2 scalp, 24 with Puregraft fat alone, and 9 with saline control. Treatments were delivered into the skin and subcutaneous layer of the scalp. A total of 40 cm2 of scalp was treated and macrophotography and global photography were obtained at baseline and at 6, 24, and 52 weeks. RESULTS:A total of 71 patients tolerated the procedures well. No unanticipated associated adverse events were reported. When evaluating all patients at 24 weeks, there were no statistical differences between any of the treatment groups with respect to nonvellus (terminal) hair counts or width. There were increases (mean change from baseline) in terminal hair count for the low-dose ADRC group in the Norwood Hamilton 3 subgroup at week 6 (13.90 ± 16.68), week 12 (11.75 ± 19.42), week 24 (16.56 ± 14.68), and week 52 (2.78 ± 16.15). For this subgroup, the difference in hair count between the low-dose ADRC group and no-fat saline control was statistically significant (P = 0.0318) at week 24. CONCLUSIONS:Puregraft fat and ADRCs are safe and well tolerated. In early male hair loss, this therapy demonstrated a statistically significant increase in terminal hair counts relative to the control population at 24 weeks and represents a promising approach for early androgenetic alopecia. LEVEL OF EVIDENCE: 2: