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NCT01988584 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children With Cerebral Palsy (CP).
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01988584 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 20 participants.
The verdict
NCT01988584, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and effectiveness of two types of stem cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10 years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord blood will be enrolled into the study. The study involves one baseline/treatment visit and 3 follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be randomized to a placebo control group at the baseline/treatment visit. Parents will not be told if their child received stem cells or a placebo until the 12 month follow-up visit. At that time parents may elect to have their child receive the stem cell treatment; either bone marrow harvest or umbilical cord blood if banked with CBR. All study visits will be conducted at the UTHealth Medical School and Children's Memorial Hermann Hospital in Houston, Texas. As of 1/21/2014 we have met our enrollment limit for children without banked cord blood undergoing bone marrow harvest for stem cells.
Interventions
- BIOLOGICAL umbilical cord blood (hUCB) cells
- DRUG Saline Infusion (Placebo)
- BIOLOGICAL bone marrow derived mononuclear cells (BMMNCs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-02-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01988584
The ClinicalTrials.gov registry entry for NCT01988584 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which umbilical cord blood (hUCB) cells is the first listed.
NCT01988584 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01988584 about?
NCT01988584 is a clinical study titled "Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children With Cerebral Palsy (CP).". The purpose of this study is to compare the safety and effectiveness of two types of stem cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10 years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord blood will be enrolled into ...
What is the current status of trial NCT01988584?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-11. Estimated completion is 2018-02-21.
What interventions are being tested in trial NCT01988584?
The interventions under investigation include: umbilical cord blood (hUCB) cells (BIOLOGICAL), Saline Infusion (Placebo) (DRUG), bone marrow derived mononuclear cells (BMMNCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01988584?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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