NCT05210452

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 14, 2022

Last Update Submit

January 14, 2022

Conditions

Alopecia

Outcome Measures

Primary Outcomes (2)

  • Number of cured patients

    Number of cured patients with significant clinical improvement

    6 month

  • Number of cured patients

    Number of cured patients with significant clinical improvement

    1 year

Study Arms (2)

Patients with alopecia receiving standard treatment and follicular stem cells

EXPERIMENTAL

Patients with alopecia receiving standard treatment and autologous follicular stem cells

Biological: Follicular stem cellsOther: Standard treatment according to the clinical protocols

Patients with alopecia receiving standard treatment

ACTIVE COMPARATOR

Patients with alopecia receiving standard treatment

Other: Standard treatment according to the clinical protocols

Interventions

Follicular stem cellsBIOLOGICAL

Cultured autologous follicular stem cells

Patients with alopecia receiving standard treatment and follicular stem cells
Standard treatment according to the clinical protocolsOTHER

Standard treatment of alopecia according to the clinical protocols

Patients with alopecia receiving standard treatmentPatients with alopecia receiving standard treatment and follicular stem cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Zinaida Kvacheva

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

    STUDY DIRECTOR

Central Study Contacts

Zinaida Kvacheva

CONTACT

+375173332223kvachzb@tut.by

Hanna Paleshka

CONTACT

+375173332223renovacio888@yandex.ru

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share