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

Lateral Epicondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811145
• Other study ID #: CTL/LE/01/0514
• Status: Completed
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2019
• Source: Cell Therapy Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

Biological:
• Tendoncel
Platelet lysate gel

Other:
• Placebo control gel
Placebo control gel

Locations

Country	Name	City	State
Greece	Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Cell Therapy Ltd.	George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	Baseline
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	Day 23 (end of treatment).
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	4 weeks follow up
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	6 weeks follow up.
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	3 months follow up.
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire	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.	Mean of 47 weeks follow up.
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	Baseline
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	Day 23.
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	4 week follow up.
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	6 week follow up.
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	3 months follow up
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.	Mean of 47 weeks follow up.
Primary	Pain free grip strength	Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).	Baseline
Primary	Pain free grip strength	Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).	Day 23
Primary	Pain free grip strength	Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).	Mean of 47 weeks follow up (final follow up).
Secondary	Safety - Number of participants in each group with adverse events.	Measured by participant questionnaire. Comparison of the number of participants in each group with cutaneous events - "redness", "rash", "swelling" or changes at gel site. Classed as none, mild, moderate or severe. Plus any other event mentioned by the participants.	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.
Secondary	Safety: Immune response - blood IgE levels. Difference between test and control groups.	Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.	Baseline
Secondary	Safety: Immune response - blood IgE levels. Difference between test and control groups.	Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.	Day 7
Secondary	Safety: Immune response - blood IgE levels. Difference between test and control groups.	Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.	Day 23
Secondary	Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.	Measurement of blood IgE levels. Comparison of the number of participants in each group, test and control, with a normal baseline reading of blood IgE and a subsequently elevated IgE reading. Normal is <100IU/mL.	Baseline, day 7 and day 23.

External Links

•   Ahmad et al., (2013)