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

This study is currently recruiting participants.
Verified July 2012 by Kasiak Research Pvt. Ltd.
Sponsor:
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01668862
First received: July 17, 2012
Last updated: August 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Lateral Epicondylitis (Tennis Elbow)
 Biological: Autologous Human Platelet Lysate
Drug: Corticosteroid
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kasiak Research Pvt. Ltd.:

Primary Outcome Measures:
  • Change in Visual Analog Score (VAS) [ Time Frame: Day 0, Month 1, Month 2, End of Study - Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient rated tennis elbow evaluation (PRTEE Score) [ Time Frame: Day 0, Month 1, Month 2, End of study-Month 3 ] [ Designated as safety issue: No ]
  • The American Shoulder and Elbow Society score [ Time Frame: Dya 0, Month 1, Month 2, End of study-Month 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Autologous Human Platelet Lysate
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
Other Name: Corticosteroid

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668862

Contacts
Contact: Kaushal Shah, Phd +91-22-41173472 kaushal.shah@kasiakresearch.com

Locations
India
Kasiak Research Pvt Ltd Recruiting
Thane, Maharashtra, India, 400610
Contact: Kaushal Shah, Phd     +91-22-4117472     kaushal.shah@kasiakresearch.com    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01668862     History of Changes
Other Study ID Numbers: KRPL/HPL-TE/11-12/003
Study First Received: July 17, 2012
Last Updated: August 16, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013