Treatment of Alopecia Using Follicular Stem Cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Alopecia

Treatments: Other: Standard treatment according to the clinical protocols; Biological: Follicular stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05210452

IBCE_FollCells

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Patients with alopecia receiving standard treatment and follicular stem cells

Experimental group

Description:

Patients with alopecia receiving standard treatment and autologous follicular stem cells

Treatment:

Biological: Follicular stem cells

Other: Standard treatment according to the clinical protocols

Patients with alopecia receiving standard treatment

Active Comparator group

Description:

Patients with alopecia receiving standard treatment

Treatment:

Other: Standard treatment according to the clinical protocols