An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Tendoncel
Placebo control gel
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Topical, Gel, Platelet, Growth factor, Regenerative
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.
Sites / Locations
- Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tendoncel
Placebo control gel
Arm Description
Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.
Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03811145
First Posted
January 16, 2019
Last Updated
December 11, 2019
Sponsor
Cell Therapy Ltd.
Collaborators
George Papanicolaou Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03811145
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cell Therapy Ltd.
Collaborators
George Papanicolaou Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Topical, Gel, Platelet, Growth factor, Regenerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tendoncel
Arm Type
Experimental
Arm Description
Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.
Arm Title
Placebo control gel
Arm Type
Placebo Comparator
Arm Description
Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.
Intervention Type
Biological
Intervention Name(s)
Tendoncel
Intervention Description
Platelet lysate gel
Intervention Type
Other
Intervention Name(s)
Placebo control gel
Intervention Description
Placebo control gel
Primary Outcome Measure Information:
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
Baseline
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
Day 23 (end of treatment).
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
4 weeks follow up
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
6 weeks follow up.
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
3 months follow up.
Title
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Description
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.
Time Frame
Mean of 47 weeks follow up.
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
Baseline
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
Day 23.
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
4 week follow up.
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
6 week follow up.
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
3 months follow up
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.
Time Frame
Mean of 47 weeks follow up.
Title
Pain free grip strength
Description
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Time Frame
Baseline
Title
Pain free grip strength
Description
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Time Frame
Day 23
Title
Pain free grip strength
Description
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Time Frame
Mean of 47 weeks follow up (final follow up).
Secondary Outcome Measure Information:
Title
Safety - Number of participants in each group with adverse events.
Description
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.
Time Frame
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.
Title
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Description
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Time Frame
Baseline
Title
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Description
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Time Frame
Day 7
Title
Safety: Immune response - blood IgE levels. Difference between test and control groups.
Description
Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.
Time Frame
Day 23
Title
Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.
Description
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.
Time Frame
Baseline, day 7 and day 23.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Givissis Panagiotis, MD
Organizational Affiliation
Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23997125
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.
Results Reference
background
Links:
URL
https://online.boneandjoint.org.uk/doi/pdf/10.1302/0301-620X.95B9.29285
Description
Ahmad et al., (2013)
Learn more about this trial
An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
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