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)
Overview
- Phase
- Phase 1
- Intervention
- Autologous Human Platelet Lysate
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Sponsor
- Kasiak Research Pvt. Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Visual Analog Score (VAS)
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with clinical diagnosis of tennis elbow within the last 3 months
- •Subjects both male and female, aged 18-60 years (both inclusive)
- •Subjects who are willing to give informed consent and adhere to the study protocol
Exclusion Criteria
- •Subjects aged less than 18 and more than 60 years
- •Subjects with autoimmune diseases
- •Subjects with immuno-compromised system
- •Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
- •Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
- •Subjects who have received treatment with corticosteroid injections within the last 6 months
Arms & Interventions
Study arm A
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
Intervention: Autologous Human Platelet Lysate
Control Arm B
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Intervention: Corticosteroid
Outcomes
Primary Outcomes
Change in Visual Analog Score (VAS)
Time Frame: Day 0, Month 1, Month 2, End of Study - Month 3
Secondary Outcomes
- Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3(Day 0, End of study - Month 3)