Clinical trial NCT03811145: An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Epicondylitis
Keywords: Topical
Gel
Platelet
Growth factor
Regenerative
Lead sponsor: Cell Therapy Ltd.
Sponsor class: INDUSTRY
Collaborators: name: George Papanicolaou Hospital
First posted: 2019-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Lateral epicondylitis, also called "tennis elbow" is a common condition affecting 1 to 3% of the population; most commonly individuals aged 35 to 55 years. It is frequently self limiting but can lead to refractory symptoms in a minority of cases. Pain is localised to the lateral epicondyle of the elbow at the point of insertion of the common extensor tendon. Although associated with repetitive movement of the extensor muscles of the forearm, frequently no precipitating cause can be discerned.

The term "epicondylitis" is a misnomer as histological investigations have revealed that there is only limited inflammation, and the term "epicondylosis" should be employed, due to the degenerative nature of the condition.

The condition is divided in to 4 stages, though progression may not occur through all four. Firstly, there is acute inflammation that is quick to resolve. Secondly, prolonged injury results in an increase in fibroblasts, vascular hyperplasia, disorganised collagen disposition and degeneration of the tendon. Thirdly, further accumulation of structural alterations leads to partial or complete tendon rupture. Stage 4 exhibits the same features as 2 and 3 but with the addition of calcification.

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. Trials of the latter two treatments give conflicting results due to variations in protocol and trial design.

Cell Therapy Ltd has developed a regenerative gel, Tendoncel, that combines isolated platelet growth factors and cellulose-derivative gel. Tendoncel consists of a proprietary platelet lysate formulation that is easy to apply to the skin.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 years and over and in good general health
* Subjects who have a diagnosis of lateral epicondylitis, Cozen's test
* Subjects who are willing to attend all study assessments and follow-up appointments
* Subjects who are able to understand the study, and are willing to co-operate with the study procedures and restrictions

Exclusion Criteria:

* Subjects have been receiving additional concurrent treatment (e.g. surgical or steroid injection) for lateral epicondylitis.
* Subjects who have medial epicondylitis or another condition of the elbow (test side only)
* Subjects who have participated in any clinical study during the previous 30 days of initiation of this study
* Subjects with a history of alcohol, substance or drug abuse in the previous 12 months
* Subjects with any significant concurrent illness
* Subjects with a heart pacemaker
* Subjects with diabetes either type I or type II (owing to possible poor wound healing)
* Subjects that have undergone surgery in the past 3 months
* Subjects with any active or significant history of skin disorders at the treatment area(s) e.g. hypo pigmentation (vitiligo)
* Subjects with any inflammatory skin condition (eczema, psoriasis, herpes simplex/complex)
* Subjects with a history (or family history) of skin cancer, skin tumours or any other malignant disease
* Subjects with any irritation, tattoo's, piercings, scars, birthmarks, or heavy presence of freckles at the treatment site(s)
* Subjects currently taking anti-histamine or steroid medication
* Subject who due to impaired mobility would not be able to undertake independent care
* Subjects who are pregnant or who are breast feeding.

Primary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: Baseline
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: Day 23 (end of treatment).
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: 4 weeks follow up
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: 6 weeks follow up.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: 3 months follow up.
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
timeFrame: Mean of 47 weeks follow up.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Baseline
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Day 23.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 4 week follow up.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 6 week follow up.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 3 months follow up
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Mean of 47 weeks follow up.
measure: Pain free grip strength
timeFrame: Baseline
measure: Pain free grip strength
timeFrame: Day 23
measure: Pain free grip strength
timeFrame: Mean of 47 weeks follow up (final follow up).
Secondary outcomes:
measure: Safety - Number of participants in each group with adverse events.
timeFrame: Day 3 (1st treatment visit), day 7, day 14, day 21, day 23 (end of treatment). Follow ups: 4 weeks, 6 weeks, 3 months and mean of 47 weeks.
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
timeFrame: Baseline
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
timeFrame: Day 7
measure: Safety: Immune response - blood IgE levels. Difference between test and control groups.
timeFrame: Day 23
measure: Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.
timeFrame: Baseline, day 7 and day 23.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Study officials:
affiliation: Aristotle University of Thessaloniki, General Hospital of Papanikolaou
name: Givissis Panagiotis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.