Exosome Effect on Prevention of Hairloss

Isfahan University of Medical Sciences

Status: Enrolling

Conditions: Hair Loss; Alopecia

Treatments: Device: Exosome

Study type: Interventional

Funder types: Other

Identifiers

NCT05658094

Isfahan Med Uni

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Exosome

Experimental group

Description:

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

Treatment:

Device: Exosome