Clinical trial NCT05658094: Exosome Effect on Prevention of Hairloss
Official title: Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hair Loss
Alopecia
Keywords: Exosome
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean total hair density (hair/cm2)
timeFrame: 0 months
measure: Change in mean total hair density (hair/cm2)
timeFrame: 3 months
measure: Change in mean total hair density (hair/cm2)
timeFrame: 6 months
measure: visual assessment before and after
timeFrame: 6 months
Secondary outcomes:
measure: Change in mean Telogen and Anagen hair density
timeFrame: 0, months
measure: Change in mean Telogen and Anagen hair density
timeFrame: 3 months
measure: Change in mean Telogen and Anagen hair density
timeFrame: 6 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Leila Dehghani
Study officials:
References: