The safety and efficacy of autologous peripheral blood mononuclear cell ex vivo culture amplified cells (Ricacell) for alopecia: Phase 1 / 2 clinical study

The safety and efficacy of autologous peripheral blood mononuclear cell ex vivo culture amplified cells (Ricacell) for alopecia: Phase 1 / 2 clinical study - Phase 1/2 clinical trial using Ricacell for alopecia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb030230286

Enrollment

Registered

2023-08-10

Start date

2023-07-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Hair loss, alopecia, baldness

Interventions

Drawing peripheral blood as material for cell processing product (Ricacell) and blood for various clinical tests. Administration of cell processing product (Ricacell) subcutaneously by injection. Pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with written informed consent. 2. Patiens are at the age of 18 to 75 at the time of informed consent. 3. Patients affected alopecia and want to receive regenerative therapy.

Exclusion criteria

Exclusion criteria: 1. Patients with HbA1c(NGSP) more than 10.0 with the medication for diabetes. 2. Patients with systemic infection. 3. Patients with severe anemia. 4. Patients with malignancy, or within 5 years after recover from malignant tumor (10 years after breast cancer), except for cutaneous basal cell carcinoma. 5. Patients with hematopoietic disorders such as leukemia, myeloproliferative disease, marrow dysplasia syndrome. 6. Pregnant women. 7. Patients infected with HIV, active HBV, HCV, HTLV, or syphilis in screening test. 8. Patients not expect to live for a year or more. 9. Patients enrolled in any other clinical trial within 90 days before informed consent. 10. Patients who can't consent not to change medication. 11. Any other reason that the Clinical Researchers may have for considering a case unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
To investigate the safety of Ricacell injection for alopecia patients. side effects, adverse events, serious advese events, clinical laboratory data, vital sign	—

Secondary

Measure	Time frame
To investigate the efficacy of Ricacell injection for alopecia patients. 1. Evaluation of the changes in appearance(evaluation is done by 3 plastic surgeon). 2. Changes of the number of hairs, hair density, hair diameter, scalp pigmentation, hair cycle. Evaluation is done by using Dermascopy or Trichoscopy. 3. QOL and patients satisfaction. 4. Changes of Hamilton-Norwood scale, Sinclair scale, Ludwig scale.	—

Measure

Time frame

To investigate the efficacy of Ricacell injection for alopecia patients. 1. Evaluation of the changes in appearance(evaluation is done by 3 plastic surgeon). 2. Changes of the number of hairs, hair density, hair diameter, scalp pigmentation, hair cycle. Evaluation is done by using Dermascopy or Trichoscopy. 3. QOL and patients satisfaction. 4. Changes of Hamilton-Norwood scale, Sinclair scale, Ludwig scale.

—

Countries

Japan

Contacts

Public ContactTaro Aikawa

Houjukai medical corporation Tokyo Skin/Plastic Surgery clinic Ginza

aikawa@ginzaikeda.com+81-3-3545-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026