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ADSTEM Inj.
ADSTEM is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue regeneration and modulates immune responses.
ADSTEM is an allogeneic adipose-derived mesenchymal stem cell therapy that promotes tissue regeneration and modulates immune responses. Used for Osteoarthritis (knee), Cartilage defects.
At a glance
| Generic name | ADSTEM Inj. |
|---|---|
| Sponsor | EHL Bio Co., Ltd. |
| Drug class | Mesenchymal stem cell therapy |
| Modality | Biologic |
| Therapeutic area | Regenerative Medicine / Orthopedics |
| Phase | Phase 3 |
Mechanism of action
ADSTEM consists of cultured mesenchymal stem cells derived from human adipose tissue, which are administered via injection to damaged or diseased tissues. These cells are believed to work through multiple mechanisms including direct differentiation into tissue-specific cells, paracrine secretion of anti-inflammatory and growth factors, and immunomodulation to reduce pathological inflammation and promote tissue repair.
Approved indications
- Osteoarthritis (knee)
- Cartilage defects
Common side effects
- Injection site pain or swelling
- Transient fever
- Allergic reaction
Key clinical trials
- Study of ADSTEM Injection for Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis (PHASE3)
- Orthobiologic Treatment for Knee Osteoarthritis (PHASE2, PHASE3)
- Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis (PHASE2)
- Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
- Safety and Efficacy of ADSTEM Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |