A phase 1 study to evaluate the potential role of mesenchymal stem cells in the treatment of chronic refractory Achilles tendinopathy

MMRI0 sites9 target enrollmentNovember 15, 2010

Overview

No summary available.

Registry

who.int

Start Date

November 15, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

MMRI

•1\. Male or female from 40 to 75 years of age.
•2\. Clinical diagnosis of mid\-substance Achilles tendonopathy based on clinical assessment, including painful arc sign and The London Hospital Test.
•3\. Symptoms of Achilles tendonopathy for at least 18 months.
•4\. Power Doppler Ultrasound confirmation of diagnosis of Achilles tendonopathy by independent specialist musculoskeletal radiologist. The tendonopathy must be maximal within the mid\-portion of the tendon (2\-7cm from insertion), and must not involve the tenoperiosteal (insertion) or musculo\-tendonous junctions.
•6\. Victorian Institute of Sport Assessment Score (VISA\-A Questionnaire) of less than or equal to 55\.
•7\. Previous treatment for Achilles tendonopathy from an Australian Registered Specialist Medical Practitioner relevant to the condition \- Orthopaedic Surgeon, Rheumatologist, Sports Physician or Rehabilitation Physician.
•8\. Completion of medical specialist prescribed, Achilles exercise program for at least 4 days per week for 8 weeks. After which, VISA\-A score must still be less or equal to 55\.
•9\. Competency to understand the information given in the Human Research and Ethics Committee (HREC) approved Achilles tendonopathy Participant Information Sheet, and must sign the consent form prior to the initiation of any study procedures.

•1\. Insertional Achilles tendonopathy, or muscle\-tendon junction tendonopathy, as defined by an ultrasound scan.
•2\. Persisting full thickness tendon defect (e.g. full thickness tear which would not provide tendon construct.)
•3\. Evidence of underlying inflammatory or rheumatological disorder.
•4\. Calcific tendonopathy, or other abnormal tissue within the mid\-portion of the Achilles tendon. (Note ectopic calcification, at the Achilles tendon insertion on the calcaneus would not constitute an exclusion criteria).
•5\. Tendonopathy associated with or aggravated by the recent use of medication known to cause tendonopathy (e.g. Fluoroquinones)
•6\. Either Achilles surgery within previous 6 months, or persistence of non\-dissolving surgical material (e.g. sutures visible on ultrasound).
•7\. Local injection of corticosteroid or potential growth factors (e.g. Autologous Blood or Platelet Rich Plasma) within previous 3 months of potential MSC injection.
•8\. Recent use of oral corticosteroids within 3 months of potential MSC injection.
•9\. Inability to perform, or poor compliance to undertake, an exercise rehabilitation program. This will include assessment for co\-existing conditions (e.g. osteoarthritis of the knee/ankle).
•10\. Bilateral tendonopathy whereby the principal investigator believes disease on the contralateral side may affect ability to undertake rehabilitation exercise program.