Treatment of Alopecia Using Follicular Stem Cells

Study Overview
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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.

Official Title
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Treatment of Alopecia Using Follicular Stem Cells

Conditions
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Alopecia

Intervention / Treatment
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* Biological: Follicular stem cells
* Other: Standard treatment according to the clinical protocols


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with alopecia receiving standard treatment and follicular stem cells<br>Patients with alopecia receiving standard treatment and autologous follicular stem cells | Biological: Follicular stem cells<br>* Cultured autologous follicular stem cells<br>Other: Standard treatment according to the clinical protocols<br>* Standard treatment of alopecia according to the clinical protocols<br>|
| Active Comparator: Patients with alopecia receiving standard treatment<br>Patients with alopecia receiving standard treatment | Other: Standard treatment according to the clinical protocols<br>* Standard treatment of alopecia according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |