Tendinopathy Clinical Trial
Official title:
Autologous Stem Cells in Achilles Tendinopathy
This study is looking at a new treatment, using the patient's own stem cells (the repair cells of the body), to see whether this can help reduce pain and promote healing of the Achilles tendon, without side effects.
Tendon disorders compromise pain free activity and often progress to chronic pain with a
major impact on quality of life. More than 85,000 patients each year see their general
practitioner (GP) with Achilles Tendinopathy (AT) which affects the lower leg in young and
middle aged adults. The main treatment is physiotherapy, although surgery is eventually
considered in 25-45%of patients, an intervention that requires several months of
immobilisation and has unpredictable outcomes.
Other treatments include, shockwave therapy, Platelet Rich Plasma (PRP) (a blood injection
of platelet rich plasma) and steroid injections, but other than physiotherapy non have been
shown to be better than placebo. There is a need for improved nonsurgical treatments. There
is an established treatment in horses that involves injection of the horses own stem cells
into the tendon, which has been shown to be effective but has never been used in man. We
wish to translate the technology to humans and propose a pilot phase II trial to establish
the safety of stem cells implanted in diseased human tendon. We aim to study 10 patients
with chronic mid substance achilles tendinopathy to assess safety as our primary outcome
measure. In addition we capture clinical outcomes scores and ultrasound appearances. Other
than the stem cell injection, all assessments will be non invasive. Participants will be
otherwise healthy adults, aged 18-70 and recruited from routine outpatient clinics at the
Royal National Orthopaedic Hospital, presenting with a painful heel, diagnosed by a
specialist as Achilles tendinopathy, and having already undergone a minimum of 6 months of
physiotherapy. Each participant will have 6 months follow up. This study will help inform a
larger clinical trial in the future for which a further ethics application will be made.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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