Exosomes + Microneedling for Male Pattern Baldness

Overseen By Eyal K Levit, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Levit Dermatology

Must not be taking: Hair loss treatments

Disqualifiers: Chemotherapy, Radiation, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 months

100 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you have not taken any medications or treatments for hair loss in the last six months. If you are currently on such treatments, you would need to stop them to participate.

What data supports the effectiveness of the treatment AGE ZERO™ EXOSOMES for male pattern baldness?

Research suggests that exosomes, which are tiny particles derived from cells, can promote hair growth by activating hair follicle cells and encouraging the hair growth cycle. Studies have shown that exosomes from sources like bovine colostrum can help hair regrow in a way similar to existing treatments like minoxidil, without causing skin irritation. ^{1 2 3 4 5}

Is the combination of exosomes and microneedling safe for treating hair loss?

Research on exosomes and microneedling for hair loss suggests they are generally safe, with studies showing no significant adverse effects like skin rashes when using exosomes derived from bovine colostrum. Microneedling has been used to enhance drug delivery with reduced side effects compared to traditional methods. ^{1 3 6 7 8}

How does the treatment Exosomes + Microneedling for Male Pattern Baldness differ from other treatments?

This treatment is unique because it combines exosomes, which are tiny particles that can promote hair growth by activating hair follicle cells, with microneedling, a technique that creates tiny punctures in the skin to enhance absorption and stimulate hair growth. Unlike traditional treatments like minoxidil or finasteride, this approach uses a novel mechanism to potentially improve hair regeneration. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of this study is to determine whether Wharton's Jelly mesenchymal stem cell-derived exosome microneedling on the scalp is an effective treatment for Androgenetic Alopecia (pattern hair loss).

Research Team

Eyal K Levit, M.D.

Principal Investigator

Owner and chief physician

Eligibility Criteria

This trial is for men and women with Androgenetic Alopecia, which includes male pattern baldness and alopecia areata. Participants should be looking for treatment options.

Inclusion Criteria

I am losing my hair and have been diagnosed with Androgenetic Alopecia.

Exclusion Criteria

Patients who are currently immunocompromised or have a low white count making patients prone to infections.

I haven't used any treatments for hair loss in the last 6 months.

I do not have open wounds or skin conditions like eczema on my scalp.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical applications of WJMSC-exosomes and microneedling in 4 sessions over 4 months

4 months

4 visits (in-person)

Follow-up

Participants are monitored for changes in hair growth and adverse events

8 months

Monthly visits (in-person)

Treatment Details

Interventions

• AGE ZERO™ EXOSOMES

Trial Overview The study tests the effectiveness of microneedling the scalp with two different doses of exosomes derived from Wharton's Jelly mesenchymal stem cells to treat hair loss.

Participant Groups

Group I: 50 billion exosome group Experimental Treatment 1 Intervention

This arm receives 50 billion WJMSC-exosome treatment on one half of the aforementioned treatment area and an equivalent volume of placebo on the contralateral half of the treatment area.

Group II: 5 billion exosome group Experimental Treatment 1 Intervention

This arm receives 5 billion WJMSC-exosome treatment on one side of the aforementioned treatment area and an equivalent volume of placebo on the contralateral half of the treatment area.

Who Is Running the Clinical Trial?

Levit Dermatology

Lead Sponsor

Trials

1

Recruited

100+

Dorisca Research Consulting, LLC

Collaborator

Trials

1

Recruited

100+

ResilielleTM Age ZeroTM Exosomes

Collaborator

Trials

1

Recruited

100+

References

1. England pubmed.ncbi.nlm.nih.gov

Mesenchymal stromal cell-derived magnetic nanovesicles for enhanced skin retention and hair follicle growth. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Hair restoration approaches for early onset male androgenetic alopecia. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Potential of Colostrum-Derived Exosomes for Promoting Hair Regeneration Through the Transition From Telogen to Anagen Phase. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Viable terminal scalp hair follicles constitute a necessary and sufficient biological end-organ that conditions clinical efficacy of finasteride in males with male pattern hair loss without implying reversal of miniaturized follicles. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Neural progenitor cell-derived nanovesicles promote hair follicle growth via miR-100. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Dissolving Microneedle Patch Integrated with Microspheres for Long-Acting Hair Regrowth Therapy. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fabrication of carboxymethyl cellulose/hyaluronic acid/polyvinylpyrrolidone composite pastes incorporation of minoxidil-loaded ferulic acid-derived lignin nanoparticles and valproic acid for treatment of androgenetic alopecia. [2023]

8. Denmark pubmed.ncbi.nlm.nih.gov

Combatting ageing in dermal papilla cells and promoting hair follicle regeneration using exosomes from human hair follicle dermal sheath cup cells. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Engineered extracellular vesicle mimetics from macrophage promotes hair growth in mice and promotes human hair follicle growth. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Macrophage-Derived Extracellular Vesicle Promotes Hair Growth. [2021]