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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: Completed Phase 1 study of Osteogenesis Imperfecta Type II and Osteogenesis Imperfecta Type III, sponsored by Nationwide Children's Hospital.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01061099 record still lists
NCT01061099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01061099's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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