A Phase 1/2 interventional study of UDI-001 in Cerebral Palsy and Periventricular Leukomalacia, sponsored by Rohto Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 12 Months to 24 Months. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Rohto Pharmaceutical Co., Ltd. · Phase 1/2, Interventional, and Treatment
UDI-001 is administered to pediatric patients with cerebral palsy attributed to periventricular leukomalacia (PVL) multiple times to investigate its safety and efficacy.
This is the first study of UDI-001 to be administered to children. Pediatric patients with cerebral palsy attributed to PVL are enrolled to the study and umbilical cord derived mesenchymal stromal cells (UC-MSCs) are administered to those patients multiple times intravenously. Safety and efficacy of UC-MSCs are evaluated for 52 weeks after the first administration.
1,937 studies on the registry are indexed under Cerebral Palsy; 457 are open to participants now.
This study's enrollment of 6 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Rohto Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Four cycles with 8 administrations
Biological: UDI-001
2.5 x 10\^6 cells/kg of UDI-001 are administered intravenously. One cycle consists of twice a week administrations.
Safety: Adverse Event
Adverse events which appear in the participants after the treatment
Time frame: until Week 52
Gross Motor Function Measure Score (GMFM Score)
Difference and change in GMFM score
Time frame: baseline to Week 52
Gross Motor Function Classification System (GMFCS)
Improvement rate of GMFCS
Time frame: baseline to Week 52
Function Independence Measure for Children (WeeFIM)
Change in WeeFIM score
Time frame: baseline to Week 52
Kyoto Scale of Psychological Development Test 2001 (KSPD)
Change in and Improvement rate of KSPD
Time frame: baseline to Week 52
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Jul 2023, 25 months.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Rohto Pharmaceutical Co., Ltd.