Investigating the Preliminary Safety and Efficacy of Umbilical Cord Blood Serum-Derived Extracellular Vesicles versus Autologous Platelet Rich Plasma and Minoxidil for Treatment of Androgenic Alopecia

Preliminary investigation of the level of safety and effectiveness of extracellular vesicles derived from umbilical cord blood serum in comparison with the platelet-rich autologous plasma group and the minoxidil group in the treatment of androgenic hair loss.

Explanatory clinical trial with control group, parallel groups, single-blinded, non-randomized, phase 1 and 2 on 30 patients

Basic information, including demographic and clinical information, is collected through a questionnaire when the patients visit the SSRC of Tehran University of Medical Sciences, and the patients are divided into 3 groups of 10 people. The first group is treated with umbilical cord blood serum, the second group with autologous PRP, and the third group with topical minoxidil. In groups 1 and 2, the solution is injected into the scalp for 4 sessions with 1-month intervals. In group 3, patients apply the solution daily for 4 months.

Inclusion criteria: women and men with hereditary hormonal hair loss, age 18 years or older and less than 55 years, Hamilton score 2 to 5 in men and Ludwig score 1 to 3 in women, complete patient consent to participate in the project. Exclusion criteria: platelet disorders or thrombocytopenia, patients receiving anticoagulants, patients with malignancy.

Patients are divided into 3 groups of 10 people. The first group was treated with extra vesicles derived from umbilical cord blood serum, the second group was treated with autologous PRP, and the third group was treated with topical minoxidil.

Hair follicle density per surface unit, hair follicle shaft thickness

Protocol Amendments Due to the lack of simultaneous enrollment of all patients and the impossibility of delaying study initiation, initial and replacement patients were allocated to the study groups using a convenience-based, non-randomized approach. To improve sample diversity, efforts were made to maintain a balanced distribution of men and women and to include patients from different registration regions. Considering the limitations in randomization, the study results are reported as pilot/preliminary findings. Before study initiation, because of operational difficulties in maintaining full blinding, it was decided that the study would be conducted as a single-blind trial. Patients and the physicians performing visits and injections, who operated independently from the main study team, remained unaware of treatment allocation, whereas personnel responsible for patient recruitment, product preparation, communication, and study analysis and documentation were unblinded. Given the inclusion and exclusion criteria and the limited availability of eligible participants, the planned age range was expanded from 18–50 years to 18–55 years before the start of the study. In the initial study proposal, biometric assessments were planned every month to augment data collection. However, monthly assessments were considered burdensome for participants; therefore, before study initiation, it was decided that biometric evaluations would be performed every two months in three main phases, focusing on the collection of essential data. In the initial study proposal, a six-month follow-up period was planned based on common practice in similar clinical studies. During the course of the study, difficulties with participant adherence to prolonged follow-up visits were observed. Considering the challenges in maintaining patient participation and the feasibility of continued follow-up, the research team decided to conduct a single formal follow-up visit four months after treatment cessation. Participants remained able to contact the study team and report any adverse events or therapeutic changes for up to one year, and no additional reports were received.

In this study, the participant and the care providers, doctor and nurse, will be unaware of the type of treatment until the end of the study.

All data can be shared after de-identifying individuals.

Six months after the publication and printing of the article

Academic researchers and experts

In order to analyze data related to study outcomes

etaghiabadi@sina.tums.ac.ir

It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months.