Alopecia
Conditions
Interventions
SHED-CM injection(once a month for three months)
After SHED-CM injection (once a month for three months), one dose of Rigenera, followed by another SHED-CM injection (once a month for three months)
A
Sponsors
Tokyo Midtown Center for Advanced Medical Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Blood test criteria RBC: at least 3000,000/microL Hemoglobin: at least10.0 g/dL Hematocrit: at least 30.0% WBC: between 3,000-12,000/microL Platelets: at least 100,000/microL 2) no scalp inflammation 3) no systemic symptoms such as fever, lethargy, etc. 4) negative for HIV and syphilis serological tests within 12 weeks from the time of criteria assessment 5) no duplication with other clinical trial while participating in this study 6) ability to comprehend and give written consent to this clinical study
Exclusion criteria
Exclusion criteria: 1) those who were diagnosed as having alopecia areata subtype 2) those with nickel allergy (in case of RIGENERA treatment) 3) those with connective tissue disease or systemic diseases such as chronic thyroiditis which are associated with alopecia 4) those with hair loss due to infection or malignant tumor 5) those with immunosuppressive treatment 6) those with diagnosis of malignant tumor (including pre-cancerous lesions), except for those who have no signs of recurrence for 5 years after being diagnosed as complete remission following the standard cancer treatment 7) those with skin diseases that could affect the scalp such as seborrheic dermatitis, scalp psoriasis, atopic dermatitis, etc.) and keloids 8) those with autoimmune diseases, hematological diseases, platelet dysfunction 9) those with heart failure, renal stone, severe renal failure, liver dysfunction, hypothyroidism 10) those with fever associated with acute infection 11) those suspicious of having immunodeficiency or opportunistic infection 12) those taking anticoagulant therapy 13) those who cannot commute to the study site 14) those who are diagnosed as being difficult to undergo treatment due to the presence of mental illness or mental symptoms 15) those who are not appropriate to participate in the study according to the doctor's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phototrichogram of injection site, vital signs, and adverse events until 6 month after starting treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair density, hair diameters, and vellus hair percentage before and after 6 months of treatment | — |
Countries
Japan
Contacts
Public ContactKyoko Uemura
Advanced Medical Care Inc. Aging Care Division
Outcome results
None listed