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

Lateral Epicondylitis (Tennis Elbow) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01668862
• Other study ID #: KRPL/HPL-TE/11-12/003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 17, 2012
• Last updated: August 16, 2012
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Kasiak Research Pvt. Ltd.
• Contact: Kaushal Shah, Phd
• Phone: +91-22-41173472
• Email: kaushal.shah[@]kasiakresearch.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lateral Epicondylitis (Tennis Elbow)
• Tennis Elbow

Intervention

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

Locations

Country	Name	City	State
India	Kasiak Research Pvt Ltd	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Kasiak Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient rated tennis elbow evaluation (PRTEE Score)		Day 0, Month 1, Month 2, End of study-Month 3	No
Other	The American Shoulder and Elbow Society score		Dya 0, Month 1, Month 2, End of study-Month 3	No
Primary	Change in Visual Analog Score (VAS)		Day 0, Month 1, Month 2, End of Study - Month 3	No
Secondary	Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3		Day 0, End of study - Month 3	No