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Treatment of Alopecia Using Follicular Stem Cells

Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05210452
Collaborator
Belarusian State Medical University (Other)
30
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Follicular stem cells
  • Other: Standard treatment according to the clinical protocols
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Alopecia Using Follicular Stem Cells
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with alopecia receiving standard treatment and follicular stem cells

Patients with alopecia receiving standard treatment and autologous follicular stem cells

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
Active Comparator: Patients with alopecia receiving standard treatment

Patients with alopecia receiving standard treatment

Other: Standard treatment according to the clinical protocols
Standard treatment of alopecia according to the clinical protocols

Outcome Measures

Primary Outcome Measures

  1. Number of cured patients [6 month]

    Number of cured patients with significant clinical improvement

  2. Number of cured patients [1 year]

    Number of cured patients with significant clinical improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Belarusian State Medical University

Investigators

  • Study Director: Zinaida Kvacheva, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier:
NCT05210452
Other Study ID Numbers:
  • IBCE_FollCells
First Posted:
Jan 27, 2022
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of Jan 27, 2022