An Investigation of Tendoncel, a Novel Topical Platelet Lysate Gel, in the Treatment of Lateral Epicondylitis
NCT03811145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-12-12
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
Interventions
- BIOLOGICAL
-
Tendoncel
Platelet lysate gel
- OTHER
-
Placebo control gel
Placebo control gel
Sponsors & Collaborators
-
George Papanicolaou Hospital
collaborator OTHER -
Cell Therapy Ltd.
lead INDUSTRY
Principal Investigators
-
Givissis Panagiotis, MD · Aristotle University of Thessaloniki, General Hospital of Papanikolaou
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- Greece
Study Locations
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