NCT01668862

A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)

A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kasiak Research Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.

Conditions

• Lateral Epicondylitis (Tennis Elbow)

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Platelet Lysate	Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
DRUG	Corticosteroid	Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-08-20
• Last updated: 2012-08-20

Locations

1 site across 1 country: India