A Phase 2 interventional study of Tendoncel and Placebo control gel in Lateral Epicondylitis, sponsored by Cell Therapy Ltd.. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by Cell Therapy Ltd. · Phase 2, Interventional, and Treatment
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.
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.
297 studies on the registry are indexed under Tennis Elbow; 63 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 263 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Cell Therapy Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.
Biological: Tendoncel
Placebo control gel. Similar to Tendoncel but without platelet derived small molecules and growth factors. 80ul applied once a day for 21 consecutive days.
Other: Placebo control gel
Platelet lysate gel
Placebo control gel
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.
Time frame: Baseline
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.
Time frame: Day 23 (end of treatment).
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.
Time frame: 4 weeks follow up
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.
Time frame: 6 weeks follow up.
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.
Time frame: 3 months follow up.
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.
Time frame: Mean of 47 weeks follow up.
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.
Time frame: Baseline
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.
Time frame: Day 23.
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.
Time frame: 4 week follow up.
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.
Time frame: 6 week follow up.
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.
Time frame: 3 months follow up
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.
Time frame: Mean of 47 weeks follow up.
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Time frame: Baseline
Pain free grip strength
Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).
Time frame: Day 23
Pain free grip strength
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).
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.
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.
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.
Time frame: Baseline
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.
Time frame: Day 7
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.
Time frame: Day 23
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.
Time frame: Baseline, day 7 and day 23.
Plan to share: No
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Cell Therapy Ltd.