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

Kasiak Research

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lateral Epicondylitis (Tennis Elbow)

Treatments: Biological: Autologous Human Platelet Lysate; Drug: Corticosteroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01668862

KRPL/HPL-TE/11-12/003

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Study arm A

Other group

Description:

Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space

Treatment:

Biological: Autologous Human Platelet Lysate

Control Arm B

Other group

Description:

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Treatment:

Drug: Corticosteroid