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Treatment of Alopecia Using Follicular Stem Cells

Primary Purpose

Alopecia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Follicular stem cells
Standard treatment according to the clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients with alopecia receiving standard treatment and follicular stem cells

    Patients with alopecia receiving standard treatment

    Arm Description

    Patients with alopecia receiving standard treatment and autologous follicular stem cells

    Patients with alopecia receiving standard treatment

    Outcomes

    Primary Outcome Measures

    Number of cured patients
    Number of cured patients with significant clinical improvement
    Number of cured patients
    Number of cured patients with significant clinical improvement

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2022
    Last Updated
    January 14, 2022
    Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05210452
    Brief Title
    Treatment of Alopecia Using Follicular Stem Cells
    Official Title
    Treatment of Alopecia Using Follicular Stem Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Collaborators
    Belarusian State Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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)
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alopecia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with alopecia receiving standard treatment and follicular stem cells
    Arm Type
    Experimental
    Arm Description
    Patients with alopecia receiving standard treatment and autologous follicular stem cells
    Arm Title
    Patients with alopecia receiving standard treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients with alopecia receiving standard treatment
    Intervention Type
    Biological
    Intervention Name(s)
    Follicular stem cells
    Intervention Description
    Cultured autologous follicular stem cells
    Intervention Type
    Other
    Intervention Name(s)
    Standard treatment according to the clinical protocols
    Intervention Description
    Standard treatment of alopecia according to the clinical protocols
    Primary Outcome Measure Information:
    Title
    Number of cured patients
    Description
    Number of cured patients with significant clinical improvement
    Time Frame
    6 month
    Title
    Number of cured patients
    Description
    Number of cured patients with significant clinical improvement
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zinaida Kvacheva
    Phone
    +375173332223
    Email
    kvachzb@tut.by
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanna Paleshka
    Phone
    +375173332223
    Email
    renovacio888@yandex.ru
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zinaida Kvacheva
    Organizational Affiliation
    the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Alopecia Using Follicular Stem Cells

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