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Human Stem Cells
Human stem cells differentiate and regenerate damaged or diseased tissues by replacing lost cells and secreting therapeutic factors.
At a glance
| Generic name | Human Stem Cells |
|---|---|
| Also known as | OK99 |
| Sponsor | Celavie Bioscences, LLC |
| Drug class | Cell therapy |
| Modality | Small molecule |
| Therapeutic area | Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
Human stem cells are undifferentiated cells capable of self-renewal and differentiation into specialized cell types. When administered, they can engraft into damaged tissues, differentiate into functional cell types to replace lost tissue, and secrete paracrine factors (cytokines, growth factors) that reduce inflammation and promote endogenous repair mechanisms. The exact therapeutic mechanism depends on the specific stem cell type and indication being targeted.
Approved indications
Common side effects
- Injection site reactions
- Immune-related adverse events
- Infection
- Tumorigenicity risk
Key clinical trials
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV) (PHASE3)
- Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue (PHASE1)
- A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD (NA)
- Safety of a Single, Intravitreal Injection of 6.0M jCell (Famzeretcel) in Retinitis Pigmentosa (RP) (PHASE2)
- A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (PHASE1)
- Safety and Efficacy Study of Transplantation of Autologous CD34+ Cells Transduced With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA in Artemis (DCLRE1C) Deficient Severe Combined Immunodeficiency Patients (ARTEGENE) (PHASE1, PHASE2)
- Gene Therapy With Modified Autologous Hematopoietic Stem Cells for Patients With Mucopolysaccharidosis Type II (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Human Stem Cells CI brief — competitive landscape report
- Human Stem Cells updates RSS · CI watch RSS
- Celavie Bioscences, LLC portfolio CI