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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Kasiak Research Pvt. Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668862
First Posted: August 20, 2012
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kasiak Research Pvt. Ltd.
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]

Other Outcome Measures:
  • Patient rated tennis elbow evaluation (PRTEE Score) [ Time Frame: 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 ]

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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kasiak Research Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01668862     History of Changes
Other Study ID Numbers: KRPL/HPL-TE/11-12/003
First Submitted: July 17, 2012
First Posted: August 20, 2012
Last Update Posted: August 20, 2012
Last Verified: July 2012

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