Revasculization therapy with autologous peripheral blood mononuclear cells for the refractory skin ulcer in connective tissue disease and vasculitis.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb070190060

Enrollment

Registered

2020-03-31

Start date

2017-04-27

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

Skin ulcer in connective tissue disease and vasculitis.

Interventions

The test drug is obtained by collecting peripheral blood mononuclear cells (PBMCs) from the subject and manufacturing a specific cell processing product for administration. PBMCs are collected at a ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients have the refractory skin ulcer resisntaice to normal therapy of connective tissue disease and vasculitis. 2) Duration time (more than 3 months) or significant quality of life disorders (amputation expected in future) 3) Age of consent acquisition date is 20 years or older 4) Patients who can give written voluntary informed consent (Proxies cannot give informed consent)

Exclusion criteria

Exclusion criteria: 1) Patient with past severe allergy or adverse events of apheresis 2) Patient with current (or within the past 5 year) malignant tumor 3) Patient with acute myocardial infarction, unstable angina, myocarditis and cerebral infarction within 3 months 4) Patien with remarkable unstable circulation based on severe heart failure and arrhythmia. 5) Patient with active infection 6) Pregnant women or patients who may be pregnant 7) Patient with proliferative diabetic retinopathy (untreated or medium- and late-stage proliferative retinopathy); excludes patients who have completed treatment 8) Albumin less than 2g / dL 9) Patient judged to be inappropriate by the attending physician

Design outcomes

Primary

Measure	Time frame
Primary endpoint: The effect of skin perfusion pressure of 6 week after the first administration	—

Secondary

Measure	Time frame
Secondary endopoint 1) The effect of reduction in skin ulcer area (long diameter x short diameter) 2) The effect of visual analogue scale for pain of 6 week after the first administration 3) The transition about the effect of skin perfusion pressure after the first administration (before administration, after 2, 6, 12, 24, 52 week) 4) The transition about the skin ulcer area 5) The transition about the pain assessment 6) Period until completion of epithelialization 7) Questionnaire of QOL	—

Measure

Time frame

Secondary endopoint 1) The effect of reduction in skin ulcer area (long diameter x short diameter) 2) The effect of visual analogue scale for pain of 6 week after the first administration 3) The transition about the effect of skin perfusion pressure after the first administration (before administration, after 2, 6, 12, 24, 52 week) 4) The transition about the skin ulcer area 5) The transition about the pain assessment 6) Period until completion of epithelialization 7) Questionnaire of QOL

—

Countries

Japan

Contacts

Public ContactIkkou Kajihara

Faculty of Sciences Kumamoto University

kajiderma@gmail.com+81-96-373-5233

Outcome results

None listed

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