drugset / Trial / NCT01525667
Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip Arthroplasty
RandomizedParallel-groupDouble-blindTreatment
Summary
Local administration of PLX-PAD single dose, intra-muscular injection for the regeneration of injured gluteal musculature after Total Hip Arthroplasty (THA).
Timeline
- Start
- 2012-11
- Primary completion
- 2013-12
- Completion
- 2015-06
Outcome
Met primary endpoint
registry analysis (superiority or other test); PLX-PAD Low Dose vs Placebo; p = 0.0067; Least Square Means (LSM) Difference 25.74 (95% CI 7.61 to 43.86); Mixed Models Analysis NCT01525667 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EMIPLACEL | Cell therapy | 1.5e+08 cells | Intramuscular |
| Subject | EMIPLACEL | Cell therapy | 3e+08 cells | Intramuscular |
Indications
No indication recorded.