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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for male pattern baldness, also known as Androgenetic Alopecia. It tests whether microneedling with Wharton's Jelly stem cell-derived exosomes (tiny cell particles) can promote hair regrowth. Participants will receive varying amounts of AGE ZERO™ EXOSOMES on their scalp to assess its effectiveness compared to a placebo (a substance with no active treatment). Individuals who have experienced hair loss and have been diagnosed with Androgenetic Alopecia may qualify for this trial, provided they have not used hair loss treatments in the past six months. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

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.

Is there any evidence suggesting that AGE ZERO™ EXOSOMES are likely to be safe for humans?

Research has shown that exosome treatments are usually safe for people. In studies with similar exosome treatments, most patients experienced only mild side effects, such as temporary redness or slight swelling at the application site. A review of exosome treatments for hair restoration found no serious side effects.

This trial is in its early stages, focusing primarily on testing safety and determining the right dose. Therefore, much remains to be learned about any possible risks. However, past research has deemed exosomes from Wharton's Jelly mesenchymal stem cells safe in other treatments. It is crucial to consult a healthcare professional about potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of AGE ZERO™ EXOSOMES for male pattern baldness because they offer a novel approach compared to traditional treatments like finasteride or minoxidil. Unlike these standard options, which primarily focus on hormonal pathways or blood flow, exosomes work by delivering growth factors and other signaling molecules directly to hair follicles, potentially stimulating hair growth at the cellular level. This method could offer a more targeted and efficient way to encourage hair regrowth, with the potential for a significant impact on hair density and health. Additionally, the dual arms of the trial, one using 5 billion and the other 50 billion exosomes, aim to determine the most effective dosage, offering hope for a customized treatment approach.

What evidence suggests that this treatment might be an effective treatment for Androgenetic Alopecia?

Research has shown that exosome treatments might aid hair growth in individuals with male pattern baldness. One study found that injections of exosomes from foreskin cells increased hair density and maintained patient satisfaction. Another study suggested that exosomes from Wharton's Jelly, a tissue in the umbilical cord, may enhance hair growth, thickness, and even hair color in affected areas. In this trial, participants will receive either a 5 billion or 50 billion WJMSC-exosome treatment on one side of the treatment area, with an equivalent volume of placebo on the opposite side. Exosome treatments are generally considered safe, with no major side effects reported. These early findings indicate that exosome microneedling could effectively address hair loss. ^{1 2 3 6 7}

Who Is on the Research Team?

Eyal K Levit, M.D.

Principal Investigator

Owner and chief physician

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06482541

Study Details | NCT06482541 | Efficacy and Safety Of AGE ... Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat Men and Women With Androgenetic Alopecia ... effective treatment for Androgenetic Alopecia (pattern hair loss).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11588828/

Effectiveness of Exosome Treatment in Androgenetic ... Foreskin-derived mesenchymal stromal cells derived exosome injection increased hair density, with sustained patient satisfaction throughout the study.

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/508215

Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat ... 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 ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-1-efficacy-safety-age-zero-exosomes-to-treat-men-women-androgenetic-trial-nct06482541

Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat ... Benefits: Potential benefits include improved hair growth, increased hair thickness, and restoration of hair color in areas affected by androgenetic alopecia.

5. withpower.com withpower.com/trial/phase-1-alopecia-areata-6-2024-63861

Exosomes + Microneedling for Male Pattern Baldness Research on exosomes and microneedling for hair loss suggests they are generally safe, with studies showing no significant adverse effects like skin rashes ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.15869

Systematic review of exosome treatment in hair restoration ... The present review covers the current landscape of exosome treatment in hair restoration, with a focus on preclinical, clinical, and safety data reported thus ...

7. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-of-age-zero-exosomes-to-treat-men-and-women-with-androgenetic-alopecia

Efficacy and Safety Of AGE ZERO™ EXOSOMES To Treat ... 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 ...