Effectiveness of Apheresis Platelet-Rich Plasma Injection for Androgenic Alopecia: A Single-Arm Trial
Phase: PHASE2
Conditions: Androgenic Alopecia
Sponsor: zhang li

Autologous Platelet-rich Plasma Injection for Androgenic Alopecia 
 
This study was formally approved and initiated following clinical application review 
by the Medical Technology Committee of General Hospital of Western Theater 
Command, with the assigned project number 2023JSYY-28 and an initiation date of 
August 14, 2023. The original document is written in Chinese. The cover page with the 
Official Title of the study, and English summary of key design elements are provided 
as follows. 
 
 

 
 
 

Objective 
Androgenetic alopecia (AGA) is a progressive condition with limited optimal 
therapeutic options. While platelet-rich plasma (PRP) therapy has been explored, the 
apheresis technique offers a distinct method of PRP preparation that yields higher 
platelet purity and more consistent cellular composition compared to conventional 
centrifugation methods. This study is specifically designed to evaluate the clinical 
effectiveness of this autologous apheresis PRP and identify key predictors.  
 
Design 
Given the exploratory nature of this investigation aimed at generating preliminary 
efficacy and safety data for a specific PRP preparation method, a single-arm design was 
chosen. This single-arm trial enrolled 201 male AGA patients receiving 3-5 sessions of 
autologous apheresis PRP injections. The primary endpoint, change in the BASP 
classification, was assessed by independent, blinded physicians. Patient-reported 
outcomes were assessed one month after treatment completion using a four-item 
questionnaire covering hair quality, hair thickness, hair loss reduction, and overall 
satisfaction. Associations between treatment response and key variables, including age, 
number of sessions, baseline severity, and PRP cellular composition were analyzed. 
 
Methods 
Participants 
Eligible participants were required to meet all of the following criteria: (1) Male aged 
18-55, who had history of hair loss more than 6 months and was diagnosed with AGA 
based on Chinese guideline for diagnosis and treatment of AGA. (2) General health: 
in good health with a body weight ≥ 50 kg, no history of hypertension, diabetes, 
platelet dysfunction, or any other contraindication to PRP apheresis. (3) Treatment 
naivety: no use of finasteride, minoxidil, or any other treatment for hair loss within 

the 6 months preceding enrollment. Additionally, participants must have had no recent 
use of glucocorticoids (topical to treatment site for 1 month; systemic for 2 weeks) or 
nonsteroidal anti-inflammatory drugs (within 48 hours) prior to PRP apheresis. (4) 
Laboratory parameters: blood tests within 2 weeks before PRP apheresis meeting the 
following criteria:  hemoglobin concentration>120 g/L, hematocrit 0.30-0.50, platelet 
counts>110 × 109/L. No clinically significant abnormalities in inflammation, 
coagulation, or electrolyte panels.  
Exclusion criteria: (1) Concurrent Hair Loss Treatments: Concurrent use of 
finasteride, minoxidil, and other hair growth treatments during PRP treatments. (2) 
Incomplete treatment protocol: failure to complete a minimum of 3 consecutive PRP 
treatment sessions as per the study protocol, or failure to complete follow-up for any 
reason. 
Interventions, Blinding, and Randomization 
Before each PRP injection, photographs of the scalp were taken from four angles 
(frontal, vertex, and bilateral sides) for every participant.  All participants received 3 
or more consecutive injections of autologous PRP into the scalp, with an interval of 3 
to 5 weeks between each treatment. To ensure objective assessment, all photographs 
were anonymized by removing any time or sequence identifiers. Subsequently, these 
photographs were randomly assigned to 2 or 3 independent, blinded physicians for the 
assessment of hair loss severity. The physicians were blinded to the treatment stage 
(before- or after-treatment), patient identity, and PRP cellular composition throughout 
the grading process. 

Treatment Protocol 
Autologous PRP was prepared using a closed-system blood cell separator (NGL XCF 
3000, Nigale Biomedical, China) with disposable blood cell collection consumables, 
following the manufacturer's standardized protocol. Approximately 20–50 mL of PRP 
was harvested per session, of which 2 mL was used for quality control and the 
remainder was aseptically aliquoted into five sterile bags and stored at –80°C. 
Cellular components were quantified using an automated hematology analyzer 
(760CS, Mindray, China). Prior to injection, the treatment area was cleansed with 
sterile gauze. Topical anesthesia was achieved by applying compound lidocaine 
cream. Subsequently, the scalp was disinfected with 75% medical-grade alcohol. 
Frozen PRP aliquots were thawed to room temperature immediately before use. Using 
a 30-gauge sterile needle, rewarmed autologous PRP was administered via 
intradermal and subcutaneous injections at multiple points across the treatment area, 
with an injection volume of 0.05 mL per point at intervals of approximately 0.5 cm. 
Following the procedure, the scalp was cleansed and disinfected again. Participants 
were advised not to wash hair for the first 48 hours after treatment. In the event of 
minor bleeding or fibrin deposition at injection sites, gentle cleansing with sterile 
gauze was recommended. 
Assessment Criteria 
The severity of hair loss was graded using the Basic and Specific (BASP) 
classification criteria. Briefly, mild cases included patterns M1, M2, C1, V1, or F1; 
moderate cases included M3, C2, V2, V3, F2, or F3; severe cases were defined as C3 

or any U-type pattern. Coexistence of basic and specific types resulted in an upgrade 
to the next severity level. Based on grading by blinded, independent physicians using 
standardized photographs, a positive response was defined as an improvement of at 
least one grade in either the Basic or Specific component of the BASP system from 
Baseline to the day of the last treatment. When the physician-assessed gradings were 
inconsistent, disagreements were resolved by a third blinded assessor, with the final 
outcome determined by a majority decision. 
Patient-reported outcomes were assessed via telephone or outpatient visit one month 
after treatment completion using a four-item questionnaire covering hair quality, hair 
thickness, hair loss reduction, and overall satisfaction. Responses are recorded on a 3-
point scale: -1 (deteriorated/dissatisfied), 0 (unchanged/neutral), +1 
(improved/satisfied). The outcome will be reported as the proportion of participants 
reporting an improvement (score of +1) for each individual item. Adverse reactions 
during the treatment process were recorded. 
Statistical Analysis 
Statistical analysis was performed using SPSS 26.0 and Prism 9.0 software. 
Continuous variables were tested for normality (Shapiro-Wilk test) and were 
presented as mean ± SD or median (IQR), as appropriate. Categorical variables were 
expressed as n (%). Binary Logic Regression Analysis was used to analyze the 
relationship between the effectiveness of PRP injection treatments and age, treatment 
sessions, initial severity at diagnosis, and cellular components in PRP. A 
crosstabulation analysis was conducted to assess the association between treatment 

sessions and clinical effectiveness. Chi-square test was used to analyze the impact of 
treatment sessions on effectiveness, and Mantel-Haenszel Chi-square test was used to 
assess for a linear trend. Receiver Operating Characteristic (ROC) curve analysis was 
conducted to assess the predictive utility of PRP RBC concentrations for treatment 
failure (defined as 'no improvement'). A two-sided p-value of < 0.05 was considered 
as statistical significance. 
 
Ethical considerations 
This study was approved by the Ethics Committee of the General Hospital of the 
Western Theater Command of the Chinese People's Liberation Army(2023xjsxxm-
28). Written informed consent was obtained from all participants after a detailed 
explanation of the study procedures, potential risks, and benefits. Participant 
confidentiality would be strictly maintained by using coded identifiers for all data. 
The study adhered to the principles of the Declaration of Helsinki.