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NCT01221857 · ClinicalTrials.gov registry record · Phase 1
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
A Phase 1 study, sponsored by Gamida Cell.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01221857: Completed Phase 1 study, sponsored by Gamida Cell.
NCT01221857 is a Phase 1 study that has completed, run by Gamida Cell. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01221857, a Phase 1 study, has completed, sponsored by Gamida Cell.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies
Primary Outcome
Acute toxicity associated with the infusion of NiCord will be measured by adverse events within 24 hours post-infusion, defined as the acute toxicity period. Known adverse events associated with myeloablation and cord blood transplant were specifically monitored including fever, chills, allergic reaction/hypersensitivity, anaphylaxis, sinus bradycardia, sinus tachycardia, hypertension, hypotension, nausea, vomiting, diarrhea, dyspnea, hypoxia, hemoglobinuria, infection, flank pain and any other
Interventions
- DRUG NiCord®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01221857 record still lists
NCT01221857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which NiCord® is the first listed.
NCT01221857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01221857 about?
NCT01221857 is a clinical study titled "Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies". Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies
What is the current status of trial NCT01221857?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01221857?
The interventions under investigation include: NiCord® (DRUG).
Who is sponsoring clinical trial NCT01221857?
This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01221857's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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