Clinical Application of Stem Cell Educator Therapy in Alopecia Areata

Recruiting at 2 trial locations

Overseen By YONG ZHAO, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Throne Biotechnologies Inc.

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called Stem Cell Educator therapy for people with alopecia areata, a condition that causes hair loss. The treatment uses the patient's own immune cells exposed to stem cells to help reset the immune system. It targets patients who haven't had success with other treatments. Stem Cell Educator therapy involves circulating a patient's blood through a system that allows immune cells to interact with stem cells, aiming to reset the immune system.

Eligibility Criteria

Inclusion Criteria

Ability to provide informed consent

Must have a clinical diagnosis of AA, at least 50% hair loss involving the scalp

For female patients only, willingness to use FDA-recommended birth control (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356451.pdf) until 6 months post treatment.

Exclusion Criteria

Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.

Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)

Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stem Cell Educator therapy or topical minoxidil treatment

6 months

Visits at 1, 3, and 6 months

Follow-up

Participants are monitored for hair regrowth and immune marker changes

6 months

Follow-up visits at 1, 3, and 6 months

Treatment Details

Interventions

• Stem Cell Educator Therapy

Participant Groups

Group I: Minoxidil therapy Experimental Treatment 1 Intervention

Control subjects will receive treatment with topical 5% minoxidil

Group II: Hair regrowth by SCE Experimental Treatment 1 Intervention

AA subjects will receive Stem Cell Educator therapy. Hair regrowth will be evaluated during six-month follow-up studies.

Stem Cell Educator Therapy is already approved in China, United States for the following indications:

Approved in China as Stem Cell Educator Therapy for:

• Type 1 Diabetes

Approved in United States as Stem Cell Educator Therapy for:

• Type 1 Diabetes

Who Is Running the Clinical Trial?

Throne Biotechnologies Inc.

Lead Sponsor

Trials

7

Recruited

340+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+