Stem Cells in Umbilical Blood Infusion for CP
SCUBI-CP
Safety Study of Sibling Cord Blood Cell Infusion to Children With Cerebral Palsy
2 other identifiers
interventional
12
1 country
2
Brief Summary
This study will investigate the safety of single dose intravenous infusion of cord blood cells which were cryopreserved after the birth of a brother or sister to a child with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2016
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 26, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 20, 2021
January 1, 2021
3.5 years
February 26, 2017
January 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with abnormal clinical assessment and/or laboratory values
Safety
12 months
Secondary Outcomes (8)
Preliminary analysis of change in gross motor function
Baseline, 3 months
Preliminary analysis of change in gross motor function
Baseline, 12 months
Preliminary analysis of change in fine motor function
Baseline, 3 months
Preliminary analysis of change in fine motor function
Baseline, 12 months
Preliminary analysis of change in cognitive function
Baseline, 12 months
- +3 more secondary outcomes
Study Arms (1)
Cord blood infusion
EXPERIMENTALMatched sibling donor cord blood cell infusion
Interventions
Single dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (\>1x10\^7 cells/kg)
Eligibility Criteria
You may qualify if:
- Diagnosis of any type of CP
- CP of any severity
- A record of sibling CBU in storage at a TGA accredited private cord blood bank
- Ability to travel to one of the trial centres
- Ability to participate in assessments
- Informed consent by parent/guardian
You may not qualify if:
- presence of progressive neurological disease
- known genetic disorder
- known brain dysplasia
- immune system disorder or immune deficiency syndrome
- infectious disease markers showing up on virology screen
- evidence of cord blood unit contamination, or fewer than 10\^7 cells/kg body mass
- ventilator support
- ill health, or if the participant's medical condition does not allow safe travel
- previous cell therapy
- Botulinum toxin A within 3 months before or after infusion
- surgery within 3 months before or after infusion
- cannot obtain parent/guardian consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Murdoch Childrens Research Institutelead
- Royal Children's Hospitalcollaborator
- Children's Health Queenslandcollaborator
- Monash Healthcollaborator
- Sydney Children's Hospitals Networkcollaborator
- Cerebral Palsy Alliancecollaborator
Study Sites (2)
Lady Cilento Children's Hospital
Brisbane, Queensland, 4101, Australia
The Royal Children's Hospital
Melbourne, Victoria, 3052, Australia
Related Publications (2)
Crompton K, Novak I, Fahey M, Badawi N, Lee KJ, Mechinaud-Heloury F, Edwards P, Colditz P, Soosay Raj T, Hough J, Wang X, Paget S, Hsiao KC, Anderson P, Reddihough D. Safety of sibling cord blood cell infusion for children with cerebral palsy. Cytotherapy. 2022 Sep;24(9):931-939. doi: 10.1016/j.jcyt.2022.01.003. Epub 2022 Feb 19.
PMID: 35193825DERIVEDCrompton K, Novak I, Fahey M, Badawi N, Wallace E, Lee K, Mechinaud-Heloury F, Colditz PB, Elwood N, Edwards P, Reddihough D. Single group multisite safety trial of sibling cord blood cell infusion to children with cerebral palsy: study protocol and rationale. BMJ Open. 2020 Mar 8;10(3):e034974. doi: 10.1136/bmjopen-2019-034974.
PMID: 32152173DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dinah Reddihough, MBChB, MD
Group leader
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2017
First Posted
March 22, 2017
Study Start
March 1, 2016
Primary Completion
September 1, 2019
Study Completion
December 1, 2020
Last Updated
January 20, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months after publication of primary outcome
- Access Criteria
- 1\) Data access agreement; 2) approval by Trial Steering Committee; 3) recognised research institutions.
The de-identified data set collected for this analysis of the SCUBI-CP trial will be available six months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the SCUBI-CP Trial Steering Committee must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Should the Trial Steering Committee be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.