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Trial record 2 of 18 for:    stem cells | Hair Loss

Treatment of Alopecia Using Follicular Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05210452
Recruitment Status : Not yet recruiting
First Posted : January 27, 2022
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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
Alopecia 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of cured patients [ Time Frame: 6 month ]
    Number of cured patients with significant clinical improvement

  2. Number of cured patients [ Time Frame: 1 year ]
    Number of cured patients with significant clinical improvement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05210452


Contacts
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Contact: Zinaida Kvacheva +375173332223 kvachzb@tut.by
Contact: Hanna Paleshka +375173332223 renovacio888@yandex.ru

Sponsors and Collaborators
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Belarusian State Medical University
Investigators
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Study Director: Zinaida Kvacheva the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
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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: January 27, 2022    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical