regenecyte Purple Book BLA 125764
- BLA number
- 125764
- Proprietary names
- regenecyte
- Proper names
- HPC, Cord Blood
- Applicant
- StemCyte, Inc.
- Center
- CBER
- First observed release
- 2024-12-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | regenecyte | HPC, Cord Blood | 351(a) | >/=1.25x10E6 VIABLE CD34+ CELLS/UNIT IN >/=9x10E8 TNCs/UNIT | Injection | Intravenous | Bag | Rx | Licensed | 2024-11-21 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2025-02-01 | U | 001 | regenecyte | 351(a) | Rx | StemCyte, Inc. |
| 2025-01-01 | U | 001 | regenecyte | 351(a) | Rx | StemCyte, Inc. |
| 2024-12-01 | N | 001 | regenecyte | 351(a) | Rx | StemCyte, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-12-01 | 001 | regenecyte | 351(a) | Rx | Licensed | 2024-11-21 |