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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Lateral Epicondylitis (Tennis Elbow)

Intervention / Treatment
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* Biological: Autologous Human Platelet Lysate
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study arm A<br>Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space | Biological: Autologous Human Platelet Lysate<br>* Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space<br>|
| Other: Control Arm B<br>Subjects will receive one injection of Corticosteroid in the lateral epicondyle space | Drug: Corticosteroid<br>* Subjects will receive one injection of Corticosteroid in the lateral epicondyle space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Score (VAS) |  | Day 0, Month 1, Month 2, End of Study - Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3 |  | Day 0, End of study - Month 3 |