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NCT05210452 Clinical Trial

Treatment of Alopecia Using Follicular Stem Cells

Alopecia Clinical Trial

Official title:
Treatment of Alopecia Using Follicular Stem Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05210452
Other study ID # IBCE_FollCells
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2023

Study information
Verified date January 2022
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact Zinaida Kvacheva
Phone +375173332223
Email kvachzb@tut.by
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Follicular stem cells
Cultured autologous follicular stem cells
Other:
• Standard treatment according to the clinical protocols
Standard treatment of alopecia according to the clinical protocols

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cured patients Number of cured patients with significant clinical improvement 6 month
Primary Number of cured patients Number of cured patients with significant clinical improvement 1 year
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