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

NCT03811145 | Completed Phase 2

• 1 other identifier: CTL/LE/01/0514
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

Topical; Gel; Platelet; Growth factor; Regenerative

Outcome Measures

Primary Outcomes (15)

• 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

• 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).

• 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

• 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.

• 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.

• 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.

• 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

• 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.

• 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.

• 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.

• 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

• 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.

• Pain free grip strength

  Measured using a dynamometer. Results compared between test and control elbows, and between study and contralateral elbow (internal control).

  Baseline

• 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

• 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 Outcomes (5)

• Safety - Number of participants in each group with adverse events.

  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.

  Baseline

• Safety: Immune response - blood IgE levels. Difference between test and control groups.

  Day 7

• Safety: Immune response - blood IgE levels. Difference between test and control groups.

  Day 23

• Safety: Immune response - blood IgE levels. Number of participants in each group with a normal baseline reading and a subsequently elevated reading.

  Baseline, day 7 and day 23.

Study Arms (2)

Tendoncel

EXPERIMENTAL

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

Biological: Tendoncel

Placebo control gel

PLACEBO COMPARATOR

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

Interventions

Tendoncel BIOLOGICAL

Platelet lysate gel

Tendoncel

Placebo control gel OTHER

Placebo control gel

Placebo control gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cell Therapy Ltd.: lead
• George Papanicolaou Hospital: collaborator

Study Sites (1)

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

Thessaloniki, 57010, Greece

Location

Related 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.

  PMID: 23997125 BACKGROUND

Related Links

• Ahmad et al., (2013)

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Givissis Panagiotis, MD

  Aristotle University of Thessaloniki, General Hospital of Papanikolaou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)