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Multiple dose safety test using conditioned medium of Ricacell for tissues with local microvascular insufficiency

Multiple dose safety test using conditioned medium of Ricacell for tissues with local microvascular insufficiency

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250275
Enrollment
9
Registered
2025-08-04
Start date
2025-08-15
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

Diseases affected by local microvascular insufficiency (alopecia, skin aging, erectile dysfunction)

Interventions

Drawing peripheral blood as material for conditioned medium preparation and various clinical tests. Administration of conditioned medium subcutaneously or intramuscularly by injection under anesthesia

Sponsors

Matsubara Shinobu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with written informed consent. -Patiens are at least 18 years of age and less than 85 years old at the time of informed consent. -Patients affected alopecia and wish to receive regenerative therapy. -Patients with facial wrinkles, dryness, and other skin symptoms associated with local microvascular insufficiency and wish to receive regenerative therapy. -Patients with ED (IIEF-5 score 21 or less) who wish to be treated with regenerative medicine.

Exclusion criteria

Exclusion criteria: -Patients with severe anemia (Hb -Patients with signs of infection in the area of hair loss. -Patients with skin diseases caused by infections such as herpes and pyoderma gangrenosum. -Patients with structural defects of the penis (penile curvature, fibrosis of the penis, Peyronie's disease, etc.) -Patients with diseases that may predispose to priapism (sickle cell anemia, multiple myeloma, leukemia, etc.) -Patients whose PSA level exceeds the age-group-specific cutoff values at the initial visit. (50-64 years: 3.0 ng/mL, 65-69 years: 3.5 ng/mL, 70 years and older: 4.0 ng/mL) However, the following patients, who are considered to have PSA recurrence, are included even if more than five years have passed since their prostate cancer was cured. -Patients with persistently elevated PSA levels -Patients with newly diagnosed disease, including local recurrence or new metastatic lesions. -Patients who have undergone radical prostatectomy and whose PSA level exceeds 0.2 ng/mL at the initial visit. -Patients with a PSA level exceeding 2.0 ng/mL at the initial visit after radical radiotherapy.

Design outcomes

Primary

MeasureTime frame
Safety of multiple dose injection of Conditioned medium side effects, adverse events, serious advese events

Contacts

Public ContactSatoshi Fujimura

Juntendo University

sfujimura@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

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