Exosome Effect on Prevention of Hairloss

Placental Mesenchymal Stem Cells-derived Exosome for Hairloss

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.

Study Overview

• Status: Recruiting
• Conditions: Alopecia; Hair Loss
• Intervention / Treatment: Device: Exosome

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: leila dehghani, Dr; Phone Number: +393517261300; Email: l_dehghani2002@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 8179997781
    • Recruiting
    • Leila Dehghani
    • Contact: leila dehghani; Phone Number: +393517261300; Email: l_dehghani2002@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exosome; Exosome (100e10 particle) injections with an interval of 14 days during two months.	Device: Exosome; Each patients will receive 4 injection with an interval of 14 days during two months; Other Names: Extracellular Vesicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
visual assessment before and after	Visual Assessment using the clinical picture by a general physician	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	0, months
Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	3 months
Change in mean Telogen and Anagen hair density	Measurement of telogen and Anagen hair density before and after trial	6 months

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): May 29, 2023
• Study Completion (Anticipated): October 29, 2023

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Exosome
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: Isfahan Med Uni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No