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NCT01061099 · ClinicalTrials.gov registry record · Phase 1
Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta
A Phase 1 study of Osteogenesis Imperfecta Type II and Osteogenesis Imperfecta Type III, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01061099 is a Phase 1 study of Osteogenesis Imperfecta Type II and Osteogenesis Imperfecta Type III that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01061099, a Phase 1 study of Osteogenesis Imperfecta Type II and Osteogenesis Imperfecta Type III, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI). Participants will receive MSC infusions approximately every 4 months to complete a total of 6 infusions over 20 months. Participants will be followed for 4 months post their last MSC infusion.
Conditions Studied
Interventions
- BIOLOGICAL Mesenchymal Stromal Cells
Study Locations (1)
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01061099
The ClinicalTrials.gov registry entry for NCT01061099 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Osteogenesis Imperfecta Type II appearing as the primary indexed condition, and to 1 intervention - of which Mesenchymal Stromal Cells is the first listed.
NCT01061099 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01061099 about?
NCT01061099 is a clinical study titled "Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta". This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI). Participants will receive MSC infusions approximately every 4 months to complete a total of 6 infusions over 20 months. Partic...
What is the current status of trial NCT01061099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-02. Estimated completion is 2014-02.
What conditions does trial NCT01061099 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta Type II, Osteogenesis Imperfecta Type III.
What interventions are being tested in trial NCT01061099?
The interventions under investigation include: Mesenchymal Stromal Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01061099?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01061099 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Osteogenesis Imperfecta Type II
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Osteogenesis Imperfecta Type III
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Pennsylvania
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