Trials / Completed
CompletedNCT04261335
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients With Therapeutic Hypothermia in the Dose Escalation Clinical Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Nagoya University · Academic / Other
- Sex
- All
- Age
- 4 Days – 14 Days
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CL2020 cells | 1.5 million or 15 million cells, IV on day 5 to 14 of birth |
Timeline
- Start date
- 2020-03-04
- Primary completion
- 2021-09-29
- Completion
- 2022-12-12
- First posted
- 2020-02-07
- Last updated
- 2023-10-03
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04261335. Inclusion in this directory is not an endorsement.