Exosome Effect on Prevention of Hairloss

Not Applicable

Recruiting

• Conditions: Hair Loss; Alopecia
• Interventions: Device: Exosome

• Registration Number: NCT05658094
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. Exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. The latest generation of natural products for treating hair loss is exosomes.

Detailed Description

Exosomes contain a variety of growth factors that are derived from stem cells. As they are so small, they can be hidden in the bloodstream and carry different types of proteins.

The Wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. The only FDA-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type II and III isoforms). However, these drugs have not been very perfect. Both have been associated with limited efficacy, duration of effect, and several significant side effects. Regenerative medicine using cell products is looking for a way to heal faster and less cost. Present research focus on Exosome efficacy on hairloss.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-11-05
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-05-29
• Study Completion: 2023-10-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

subjects able to read the documents and have medical coverage

Subjects have a "hair loss grade" as below criteria:

1. BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)
2. For female: Ludwig grade: Ⅰ to Ⅱ
3. For male: Norwood-Hamilton grade: III to IV
4. Hair density by phototrichogram: 60 to 190 hair/cm2
5. Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo

Exclusion Criteria

1. Sick subject in situation of emergency.
2. Subjects who have hereditary history of hairloss
3. Pregnant Females
4. Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)
5. Subjects who have a medical treatment for alopecia or having stopped it from than 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exosome	Exosome	Exosome (100e10 particle) injections with an interval of 14 days during two months.

Primary Outcome Measures

Name	Time	Method
visual assessment before and after	6 months	Visual Assessment using the clinical picture by a general physician
Change in mean total hair density (hair/cm2)	6 months	Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm\^2)

Secondary Outcome Measures

Name	Time	Method
Change in mean Telogen and Anagen hair density	6 months	Measurement of telogen and Anagen hair density before and after trial

Trial Locations

Locations (1)

Leila Dehghani; 🇮🇷 Isfahan, Iran, Islamic Republic of