Exosome Effect on Prevention of Hairloss

Alopecia Clinical Trial

Official title:

Placental Mesenchymal Stem Cells-derived Exosome for Hairloss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658094
• Other study ID #: Isfahan Med Uni
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 29, 2023

Study information

• Verified date: December 2022
• Source: Isfahan University of Medical Sciences
• Contact: leila dehghani, Dr
• Phone: +393517261300
• Email: l_dehghani2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 29, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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: ? to ?

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

Related Conditions & MeSH terms

• Alopecia
• Hair Loss

Intervention

Device:
• Exosome
Each patients will receive 4 injection with an interval of 14 days during two months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Leila Dehghani	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean total hair density (hair/cm2)	Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)	0 months
Primary	Change in mean total hair density (hair/cm2)	Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)	3 months
Primary	Change in mean total hair density (hair/cm2)	Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm^2)	6 months
Primary	visual assessment before and after	Visual Assessment using the clinical picture by a general physician	6 months
Secondary	Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	0, months
Secondary	Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	3 months
Secondary	Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	6 months