An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis

NCT ID: NCT03811145

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-11-30

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.

Conditions

Lateral Epicondylitis

Keywords

Topical; Gel; Platelet; Growth factor; Regenerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tendoncel

Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.

Group Type: EXPERIMENTAL

Tendoncel

Intervention Type: BIOLOGICAL

Platelet lysate gel

Placebo control gel

Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.

Group Type: PLACEBO_COMPARATOR

Placebo control gel

Intervention Type: OTHER

Placebo control gel

Interventions

Tendoncel

Platelet lysate gel

Intervention Type: BIOLOGICAL

Placebo control gel

Placebo control gel

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Papanicolaou Hospital

OTHER

Sponsor Role: collaborator

Cell Therapy Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Givissis Panagiotis, MD

Role: PRINCIPAL_INVESTIGATOR

Aristotle University of Thessaloniki, General Hospital of Papanikolaou

Locations

Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou

Thessaloniki, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 23997125 (View on PubMed)

Related Links

https://online.boneandjoint.org.uk/doi/pdf/10.1302/0301-620X.95B9.29285

Ahmad et al., (2013)

Other Identifiers

CTL/LE/01/0514

Identifier Type: -

Identifier Source: org_study_id