Cerebral palsy
Conditions
Interventions
1. Sibling Allo-CB, which is dissolved in 20ml saline with 2.5% human albumin plus 5% dextran, mixed with normal saline (total volume 100ml) is administered intravenously over 1 hour.
2. Prednisolone
Sponsors
Mikiya Fujieda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 1 year old and less than 7 years old at the sibling allogeneic umbilical cord blood nuclear cells (Allo-CB) infusion. 2. Recipients with cerebral palsy, or moderate and severe hypoxic ischemic encephalopathy. 3. Allo-CB from an HLA-mismatched (5/6 and 4/6 match) or matched (6/6) sibling. 4. Consent of eligible person's parent or donor's special agent.
Exclusion criteria
Exclusion criteria: 1. Recipients or donors with genetic disorder. 2. Recipients with malignant disease or brain tumor. 3. Recipients with steroid, cyclosporine, albumin or haptoglobin allergy. 4. Recipients who are decided that combined contraindicated drugs can not be stopped during administration of cyclosporine. 5. Recipients with liver dysfunction, or renal function disorder, or immunodeficiency, or uncontrolable epilepsy, or neural Bechet disease. 6. Recipients are positive for HBV, HCV, HIV, HTLV-1, and syphilis. 7. Recipients who are taking colchicine. 8. Mothers are positive for HBV, HCV, HIV, HTLV-1, and syphilis at the pregnancy. 9. Allo-CB are positive for bacterial culture, or parvovirus B19, or cytomegalovirus. 10. Recipients who are decided to be ineligible by doctors. 11. No consent of eligible person's parent or donor's special agent..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety which will be evaluated by assessing the incidence of acute infusion reactions, infections, graft versus host disease or any other adverse events for 24 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. | — |
Countries
Japan
Contacts
Public ContactKikuchi Hiroaki
Kochi Medical School Hospital
Outcome results
None listed