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Amniotic fluid injection
Amniotic fluid injection delivers bioactive components from amniotic fluid to promote tissue repair and reduce inflammation at the injection site.
Amniotic fluid injection delivers bioactive components from amniotic fluid to promote tissue repair and reduce inflammation at the injection site. Used for Osteoarthritis and joint degeneration (Phase 3).
At a glance
| Generic name | Amniotic fluid injection |
|---|---|
| Also known as | Processed Amniotic Fluid, pAF, Human Amniotic Fluid, hAF |
| Sponsor | J&M Shuler |
| Modality | Biologic |
| Therapeutic area | Orthopedics/Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
Amniotic fluid contains growth factors, cytokines, and other bioactive molecules that may stimulate regeneration and modulate immune responses. When injected into damaged or degenerative tissues, these components are thought to promote healing, reduce inflammatory signaling, and potentially restore tissue function. The exact active constituents and their individual contributions remain under investigation.
Approved indications
- Osteoarthritis and joint degeneration (Phase 3)
Common side effects
- Injection site pain or swelling
- Temporary increased inflammation
- Infection risk
Key clinical trials
- pAF for the Treatment of Osteoarthritis (PHASE1, PHASE2)
- XVIE to Treat Androgenetic Alopecia (AGA) (PHASE1, PHASE2)
- Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis (PHASE1, PHASE2)
- Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial (PHASE1, PHASE2)
- A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (PHASE3)
- Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee (PHASE3)
- Sterile Amniotic Fluid Filtrate Epidural Injection. (PHASE1, PHASE2)
- NANOVAE to Treat Knee Osteoarthritis (KOA) (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:
- Amniotic fluid injection CI brief — competitive landscape report
- Amniotic fluid injection updates RSS · CI watch RSS
- J&M Shuler portfolio CI