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Stem Cell Therapy

Exosomes + Microneedling for Male Pattern Baldness

Phase 1

Waitlist Available

Led By Eyal K Levit, M.D.

Research Sponsored by Levit Dermatology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is experiencing hair loss and is diagnosed with Androgenetic Alopecia.

Be older than 18 years old

Must not have

Patients cannot have open wounds, eczema, or psoriatic plaques on the treatment area of the scalp

Patients who are undergoing or have undergone chemotherapy and or radiation therapy within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will self-report on questionnaire during monthly visits for the entire 1-year duration

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to find out if using stem cell-derived exosomes with microneedling on the scalp can help treat pattern hair loss, also known as Androgenetic Alopecia."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or pain at the treatment site, redness, swelling, infection risk at needle entry points, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had chemotherapy or radiation therapy in the last 6 months.

Select...

I have a history of an autoimmune disorder affecting my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will self-report adverse events during monthly visits for the entire 1-year duration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will self-report adverse events during monthly visits for the entire 1-year duration

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will self-report adverse events during monthly visits for the entire 1-year duration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hair color

Hair count

Hair thickness

Secondary study objectives

Adverse events

Self-reported hair changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 50 billion exosome groupExperimental Treatment1 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 groupExperimental Treatment1 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.

0 / 4Eligibility criteria met