Stem Cell Educator Therapy for Alopecia Areata

Not currently recruiting at 2 trial locations

Overseen By YONG ZHAO, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Throne Biotechnologies Inc.

Must be taking: Topical minoxidil

Must not be taking: Immunosuppressives, Chemotherapy

Disqualifiers: Coronary artery disease, Active infection, Pregnancy, Autoimmune diseases, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new treatment option for alopecia areata (AA), a condition causing significant hair loss, sometimes affecting the entire scalp or body. The study will test the effectiveness of Stem Cell Educator Therapy, which has shown promise in treating other autoimmune diseases, against the standard topical treatment, minoxidil. Suitable candidates are those with AA experiencing at least 50% hair loss on the scalp, particularly if the hair loss has been stable or worsening for at least six months. Participants must not have used any treatments affecting AA in the past two months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

You must stop any treatments known to affect alopecia areata (AA) at least 2 months before the trial and cannot use any other treatments besides topical minoxidil for 6 months after the therapy. If you are on immunosuppressive medications, you need to stop them at least one month before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stem Cell Educator (SCE) therapy has been safe for humans in past studies. It was tested on individuals with severe alopecia areata (AA) and other autoimmune diseases. These studies found that patients experienced better hair regrowth and an improved quality of life. Importantly, no major safety issues emerged. SCE therapy uses a person’s own cells, treated with special stem cells, making it a personalized treatment.

The FDA approved minoxidil in 1988 for treating androgenetic alopecia, a different type of hair loss. This approval indicates a strong safety record in humans. Although used for a different condition, its long-term use in humans demonstrates it is generally well-tolerated.

Both treatments have undergone human testing. SCE therapy has shown promise in safety and effectiveness, while minoxidil has a long history of safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for alopecia areata, which often include topical corticosteroids or minoxidil, Stem Cell Educator Therapy is unique because it uses a novel approach to potentially restore hair growth. This therapy harnesses the power of stem cells to "educate" a patient's immune system, potentially addressing the autoimmune aspects of alopecia areata. Researchers are particularly excited about its potential to provide a more targeted and lasting solution by directly modulating the immune response, which is not typically addressed by current treatments. This innovative mechanism offers hope for more effective and durable outcomes for those struggling with hair loss due to autoimmune issues.

What evidence suggests that this trial's treatments could be effective for alopecia areata?

Research has shown that Stem Cell Educator (SCE) therapy, which participants in this trial may receive, may help treat alopecia areata (AA), a condition where the immune system attacks hair follicles, causing hair loss. Studies have found that people with severe AA experienced better hair regrowth and improved quality of life after SCE therapy. This treatment uses a person's own immune cells, treated with special stem cells from umbilical cord blood, to help reset the immune system. While more research is needed, these early results offer hope for those seeking new AA treatments. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Stem Cell Educator Therapy

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04011748

Clinical Application of Stem Cell Educator Therapy in ... Stem Cell Educator (SCE) therapy, which uses only autologous mononuclear cells that are externally exposed to cord blood stem cells, has previously been proven ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4417286/

Hair regrowth in alopecia areata patients following Stem ... Clinical data demonstrated that patients with severe AA achieved improved hair regrowth and quality of life after receiving Stem Cell Educator ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25896390/

Hair regrowth in alopecia areata patients following Stem ... Clinical data demonstrated that patients with severe AA achieved improved hair regrowth and quality of life after receiving Stem Cell Educator therapy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01673789

Stem Cell Educator Therapy in Alopecia Areata The primary study end points are 1) feasibility of the Stem Cell Educator therapy in AA, 2) preliminary evaluation of the efficacy of the therapy for improving ...

5. ctv.veeva.com ctv.veeva.com/study/clinical-application-of-stem-cell-educator-therapy-in-alopecia-areata

Clinical Application of Stem Cell Educator Therapy in Alopecia ... Adult patients ( 18 years) · Must have a clinical diagnosis of AA, at least 50% hair loss involving the scalp · For cases in which there is 80% or ...