Treatment of Alopecia Using Follicular Stem Cells

Phase 1

• Conditions: Alopecia
• Interventions: Biological: Follicular stem cells; Other: Standard treatment according to the clinical protocols

• Registration Number: NCT05210452
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of alopecia using the injections of cultured stem cells from human hair follicles,(which contain epithelial and mesenchymal cells stem cell)

Detailed Description

The aim of the project is to develop a biomedical cell product based on and stem progenitor cells of the hair follicle and dermal papilla, to study its efficacy in the treatment of alopecia.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Study Start: 2022-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Clinical diagnosis of alopecia areata, androgenic alopecia and other non-scarring hair loss
• The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
• Written informed consent

Exclusion Criteria

• Acute or chronic diseases in the stage of decompensation
• Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
• Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
• Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
• Patients are unable or unwilling to give written informed consent and / or follow research procedures
• Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with alopecia receiving standard treatment and follicular stem cells	Standard treatment according to the clinical protocols	Patients with alopecia receiving standard treatment and autologous follicular stem cells
Patients with alopecia receiving standard treatment and follicular stem cells	Follicular stem cells	Patients with alopecia receiving standard treatment and autologous follicular stem cells
Patients with alopecia receiving standard treatment	Standard treatment according to the clinical protocols	Patients with alopecia receiving standard treatment

Primary Outcome Measures

Name	Time	Method
Number of cured patients	1 year	Number of cured patients with significant clinical improvement