Status:
UNKNOWN
Clinical Application of Stem Cell Educator Therapy in Alopecia Areata
Lead Sponsor:
Throne Biotechnologies Inc.
Conditions:
Alopecia Areata
Alopecia Totalis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Alopecia areata (AA) is a common autoimmune disease that results in loss of body hair in varying degrees. The condition is estimated to affect more than 6.8 million people in the United States alone (...
Eligibility Criteria
Inclusion
- 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 more scalp hair loss, the duration of the severity of hair loss must be 10 years or less
- Stable or worsening hair loss for at least 6 months without evidence of hair regrowth
- Patients must not have received any treatments known to affect AA within 2 months of screening
- Patients must agree that they are not permitted to use any other treatment besides topical minoxidil known to affect AA during a period of 6 months after undergoing SCE therapy
- Adequate venous access for apheresis
- Ability to provide informed consent
- 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.
- Must agree to comply with all study requirements and be willing to complete all study visits
Exclusion
- AST or ALT 2 \> x upper limit of normal.
- Abnormal bilirubin (total bilirubin \> 1.2 mg/dL, direct bilirubin \> 0.4 mg/dL)
- Creatinine \> 2.0 mg/dl.
- 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
- Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.
- Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)
- Anticoagulation other than ASA.
- Hemoglobin \< 10 g/dl or platelets \< 100 k/ml
- Is unable or unwilling to provide informed consent
- Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation
- Significant cardiovascular diseases that would make use of oral minoxidil inappropriate.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04011748
Start Date
September 20 2022
End Date
July 30 2023
Last Update
January 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Throne Biotechnologies
Paramus, New Jersey, United States, 07652