Assessement of the safety of autologous umbilical cord blood cells infusions for cerebral palsy in Kochi

Assessment of the safety of autologous umbilical cord blood cells infusions for children with cerebral palsy or cerebral disorder in Kochi - CBReK

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb060190039

Enrollment

Registered

2020-03-11

Start date

2017-03-14

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

Cerebral palsy

Interventions

1. Auto-CB mixed with normal salline (total volume 100ml) are administered intravenously over 1hour. 2. Prednisolone is given 30 minutes before Auto-CB administration over 30 minutes.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age under 7 years at the autologous umbilical cord blood cells (Auto-CB) infusion. 2. Recipients with cerebral palsy, or maderate and severe hypoxic ischemic encephalopathy, or periventricular leukomalacia 3. Total cell count of Auto-CB is over 1.2E+06 cells with cell viability >60%.

Exclusion criteria

Exclusion criteria: 1. Recipients with genetic disorder. 2. Recipients with malignant disease or brain tumor. 3. Mothers are positive for HBV, HCV, HIV, HTLV-1, and syphilus at the pregnancy. 4. Recipients with steroid allergy. 5. Auto-CB are positive for bacterial culture. 6. Recipients who are decided to be ineligible by doctors. 7. No principal or parental consent.

Design outcomes

Primary

Measure	Time frame
Safety which will be evaluated by assessing the incidence of acute infusion reactions, infections, any other adverse events for 36 months.	—

Secondary

Measure	Time frame
1. Assessment of improvement in gross mot or function using gross motor function meas ure(GMFM) at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 2. Assessment of mental, speech, and social development using new edition k type devel opmental examination or WISC-IV at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 3. Serial change of EEG and brain MRI findin gs(CT findings in cases with contraindication of MRI) at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 4. Relationship among clinical improvement, total CD45 positive cell numbers of sibling A llo-CB excluding granulocytes, and HLA-match rate.	—

Measure

Time frame

1. Assessment of improvement in gross mot or function using gross motor function meas ure(GMFM) at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 2. Assessment of mental, speech, and social development using new edition k type devel opmental examination or WISC-IV at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 3. Serial change of EEG and brain MRI findin gs(CT findings in cases with contraindication of MRI) at the day before transfusion (from admission to one day before trasfusion), on discharge, 6 months later, 12 months later, and 24 months later. 4. Relationship among clinical improvement, total CD45 positive cell numbers of sibling A llo-CB excluding granulocytes, and HLA-match rate.

—

Countries

Japan

Contacts

Public ContactHiroaki Kikuchi

Kochi Medical School Hospital

kikuchi@kochi-u.ac.jp+81-88-880-2355

Outcome results

None listed

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