NCT03811145

A Double-Blind Randomised Placebo-controlled Phase IIb Clinical Trial to Study the Efficacy & Safety of a Novel Platelet Lysate Gel in the Treatment of Lateral Epicondylitis

Completed Phase 2 Last updated 11 December 2019

What this trial tests

Phase 2 trial testing Tendoncel in Lateral Epicondylitis in 30 participants. Completed in 1 November 2015.

Timeline

1 May 2014

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	Cell Therapy Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 May 2014
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	1 location across Greece

Drugs / interventions tested

• Tendoncel — full drug profile →
• Placebo control gel

Conditions studied

• Lateral Epicondylitis — all drugs for Lateral Epicondylitis →

Sponsor

Cell Therapy Ltd. — full company profile →

Who can join

18 and older, any sex, with Lateral Epicondylitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: Baseline
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: Day 23 (end of treatment).
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: 4 weeks follow up
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: 6 weeks follow up.
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: 3 months follow up.
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.
• Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
  Time frame: Mean of 47 weeks follow up.
  15 question questionnaire measuring pain and function. Total scores from 15 questions compared - pain and function combined. Scale: 10 to 100 (best to worst). Difference between test and control scores compared.

Sponsor's own description

Current treatments for lateral epicondylitis include: rest, behaviour modification and physiotherapy, anti-inflammatory medication - both steroidal and non-steroidal, and surgery. Current experimental therapies include muscle relaxants to reduce muscle tone and force on the epicondyle, laser therapy to stimulate collagen production, and blood based therapies including the injection of autologous blood and protein rich plasma.

Cell Therapy Ltd (trading as Celixir) has developed a regenerative gel that combines isolated allogeneic platelet growth factors and a cellulose-derivative gel.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances toward transformative therapies for tendon diseases.
   Freedman BR, Mooney DJ, Weber E. · · 2022 · cited 28× · PMID 36070365 · DOI 10.1126/scitranslmed.abl8814