Treatment of Alopecia Using Follicular Stem Cells

NCT ID: NCT05210452

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alopecia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with alopecia receiving standard treatment and follicular stem cells

Patients with alopecia receiving standard treatment and autologous follicular stem cells

Group Type EXPERIMENTAL

Follicular stem cells

Intervention Type BIOLOGICAL

Cultured autologous follicular stem cells

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of alopecia according to the clinical protocols

Patients with alopecia receiving standard treatment

Patients with alopecia receiving standard treatment

Group Type ACTIVE_COMPARATOR

Standard treatment according to the clinical protocols

Intervention Type OTHER

Standard treatment of alopecia according to the clinical protocols

Interventions

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Follicular stem cells

Cultured autologous follicular stem cells

Intervention Type BIOLOGICAL

Standard treatment according to the clinical protocols

Standard treatment of alopecia according to the clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zinaida Kvacheva

Role: STUDY_DIRECTOR

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

Central Contacts

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Zinaida Kvacheva

Role: CONTACT

+375173332223

Hanna Paleshka

Role: CONTACT

+375173332223

Other Identifiers

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IBCE_FollCells

Identifier Type: -

Identifier Source: org_study_id

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