Trials / Terminated
TerminatedNCT01440192
Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis
A Phase 1B, Multi-Center, Open-Label, Single Dose Study to Evaluate the Safety of Intravenous Infusion of Human Placental-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis.Sarcoidosis
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Celularity Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to assess the safety and tolerability of a single dose of PDA001 (given twice) in subjects with Stage II or III Pulmonary Sarcoidosis (PS) who are refractory to one or more of the following treatments for PS: methotrexate,immunosuppressants or cytotoxic agents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PDA001 (cenplacel-L) | 1 unit PDA001 (approximately 200 x 106 cells) IV on Days 1 \& 8 |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2011-09-26
- Last updated
- 2018-03-01
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01440192. Inclusion in this directory is not an endorsement.