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

NCT01668862 | Unknown Phase 1 DMC

• 1 other identifier: KRPL/HPL-TE/11-12/003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Score (VAS)

  Day 0, Month 1, Month 2, End of Study - Month 3

Secondary Outcomes (1)

• Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3

  Day 0, End of study - Month 3

Other Outcomes (2)

• Patient rated tennis elbow evaluation (PRTEE Score)

  Day 0, Month 1, Month 2, End of study-Month 3

• The American Shoulder and Elbow Society score

  Dya 0, Month 1, Month 2, End of study-Month 3

Study Arms (2)

Study arm A

OTHER

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

Biological: Autologous Human Platelet Lysate

Control Arm B

OTHER

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

Drug: Corticosteroid

Interventions

Autologous Human Platelet Lysate BIOLOGICAL

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

Study arm A

Corticosteroid DRUG

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

Control Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasiak Research Pvt. Ltd.: lead

Study Sites (1)

Kasiak Research Pvt Ltd

Thane, Maharashtra, 400610, India

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Anant Joshi, Dr.

  ASMI

  PRINCIPAL INVESTIGATOR

• Nicolas Antao, Dr.

  Hillway Clinic

  PRINCIPAL INVESTIGATOR

• Gauresh Palekar, Dr.

  Surya Orthopedic Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaushal Shah, Phd

CONTACT

+91-22-41173472; kaushal.shah@kasiakresearch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: August 20, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 20, 2012

Record last verified: 2012-07

Locations

IN (1)