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

August 16, 2012 updated by: Kasiak Research Pvt. Ltd.

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Thane, Maharashtra, India, 400610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Study arm A
Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space
Biological: Autologous Human Platelet Lysate
Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
OTHER: Control Arm B
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Drug: Corticosteroid
Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Patient rated tennis elbow evaluation (PRTEE Score)
Time Frame: Day 0, Month 1, Month 2, End of study-Month 3
Day 0, Month 1, Month 2, End of study-Month 3
The American Shoulder and Elbow Society score
Time Frame: Dya 0, Month 1, Month 2, End of study-Month 3
Dya 0, Month 1, Month 2, End of study-Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasiak Research Pvt. Ltd.

Investigators

  • Principal Investigator: Anant Joshi, Dr., ASMI
  • Principal Investigator: Nicolas Antao, Dr., Hillway Clinic
  • Principal Investigator: Gauresh Palekar, Dr., Surya Orthopedic Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2012

Last Update Submitted That Met QC Criteria

August 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRPL/HPL-TE/11-12/003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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