Journal of Stem Cell Research & Therapy

A double-blind randomized placebo-controlled phase IIb clinical trial to study the efficacy & safety of a Tendoncelâ?¢, a novel platelet lysate gel in the treatment of lateral epicondylitis (tennis elbow)

4^th International Conference and Exhibition on Cell & Gene Therapy

August 10-12, 2015 London, UK

Sabena Sultan1 and Panagiotis Givissis2

Scientific Tracks Abstracts: J Stem Cell Res Ther

Abstract:

Introduction: Lateral epicondylitis is a condition of the common insertion point of the extensor tendon. Currently there is
little consensus regarding optimum treatment, several treatments, such as NSAIDs and steroid injections provide short term
pain relief but do not affect the underlying pathophysiology. The condition affects 1% to 3% of the population leading to
refractory tendonitis requiring surgery in 4 to 11% of patients. Recovery from surgery and time to return to normal function
is typically 3-6 months. Growth factors derived from platelet lysate have been shown to facilitate healing in cutaneous and soft
tissue injuries. Here we report on a Phase IIb trial investigating the efficacy and safety of Tendoncel™, a novel platelet lysate gel
in the treatment of lateral epicondylitis.
Methods & Materials: 30 individuals, with a mean age of 51 years, 18 of whom were female, were randomized to either a
treatment group with Tendoncel™, a patented topical platelet lysate gel, or control group with a physically identical placebo
gel. The gels were applied once daily for 21 days with follow up over a period of 3 months. The efficacy was assessed using two
functional questionnaires (DASH and PRTEE) and pain free grip strength. Tendoncel™ safety was monitored with standardized
ADR reporting and assessed by a standardized participant questionnaire.
Results: The Tendoncel™ treatment cohort showed a statistically and clinically significant improvement in DASH and PTREE
scores at 21 days of treatment (from baseline) compared to placebo control. Pain free grip strength was a secondary measure
and was also statistically significant. There was no significant change in IgE levels. Tendoncel™ gel appeared safe and well
tolerated.
Conclusion: Tendoncel™, a novel topical platelet lysate based therapy, is both efficacious and safe in the treatment of lateral
epicondylitis.

Biography :

Sabena Sultan is currently R&D Director at Cell Therapy Limited for 4 years. She is the British Heart Foundation Principal Investigator Grant Holder, Cardiovascular
Medicine Department, Kings College London and Postdoctoral Scientist at Rayne Institute, Cardiovascular Medicine Department, University of London. She
completed PhD in Cardiovascular Medicine, Imperial College School of Medicine.
Panagiotis Givissis is currently Associate Professor of Orthopaedics, Aristotle University of Thessaloniki, from 2008 to present Orthopaedic Training Programme
in Manchester, UK. He holds Medical Degree, Orthopaedic Surgeon Specialty Degree and PhD Member and He is also the past president of Hellenic Association
of Orthopaedics Surgery and Trauma.