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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811145
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
George Papanicolaou Hospital
Information provided by (Responsible Party):
Cell Therapy Ltd.

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.


Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Biological: Tendoncel Other: Placebo control gel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tendoncel
Topically applied experimental gel - Tendoncel. 80ul applied once a day for 21 consecutive days.
Biological: Tendoncel
Platelet lysate gel

Placebo Comparator: 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.
Other: Placebo control gel
Placebo control gel




Primary Outcome Measures :
  1. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: Baseline ]
    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.

  2. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: Day 23 (end of treatment). ]
    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. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: 4 weeks follow up ]
    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. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: 6 weeks follow up. ]
    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.

  5. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: 3 months follow up. ]
    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. Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire [ Time Frame: Mean of 47 weeks follow up. ]
    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.

  7. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Baseline ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  8. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Day 23. ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  9. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 4 week follow up. ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  10. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 6 week follow up. ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  11. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 3 months follow up ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  12. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: Mean of 47 weeks follow up. ]
    30 question questionnaire measuring disabilities of the upper limb. Scale from 0 to 100 (best to worst). Difference between test and control scores compared.

  13. Pain free grip strength [ Time Frame: Baseline ]
    Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).

  14. Pain free grip strength [ Time Frame: Day 23 ]
    Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).

  15. Pain free grip strength [ Time Frame: Mean of 47 weeks follow up (final follow up). ]
    Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).


Secondary Outcome Measures :
  1. Safety - Number of participants in each group with adverse events. [ 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. ]
    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.

  2. Safety: Immune response - blood IgE levels. Difference between test and control groups. [ Time Frame: Baseline ]
    Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.

  3. Safety: Immune response - blood IgE levels. Difference between test and control groups. [ Time Frame: Day 7 ]
    Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.

  4. Safety: Immune response - blood IgE levels. Difference between test and control groups. [ Time Frame: Day 23 ]
    Measurement of blood IgE levels. Test and control averages compared. Normal is <100IU/mL.

  5. Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading. [ Time Frame: Baseline, day 7 and day 23. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811145


Locations
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Greece
Orthopaedic Clinic of Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Cell Therapy Ltd.
George Papanicolaou Hospital
Investigators
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Principal Investigator: Givissis Panagiotis, MD Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Additional Information:
Publications:
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Responsible Party: Cell Therapy Ltd.
ClinicalTrials.gov Identifier: NCT03811145    
Other Study ID Numbers: CTL/LE/01/0514
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cell Therapy Ltd.:
Topical
Gel
Platelet
Growth factor
Regenerative
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries