Clinical trial NCT01343836: Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy
Official title: The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tendinopathy
Achilles Tendon Injury
Achillodynia
Keywords: autologous tenocytes
cell therapy
eccentric exercises
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises

Detailed description: Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
* Symptoms \> 2 months
* Age 18-55 years

Exclusion Criteria:

* Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
* Condition of the Achilles tendon caused by medications such as quinolones and statins
* Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
* Antibiotics allergy (aminoglycoside group)
* A condition that prevents the patients from executing an active rehabilitation programme
* Patient has received an injection for this injury
* Patient has received surgical intervention for this injury
* Patient has already one site (left or right) included in this study
* Patient does not wish, for whatever reason, to undergo one of the two treatments
* Known pregnancy
* Nursing women

Primary outcomes:
measure: VISA-A score
timeFrame: 24 weeks
Secondary outcomes:
measure: Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)
timeFrame: 24 weeks
measure: Subjective patient satisfaction
timeFrame: 24 weeks
measure: Returning to sports level
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Leidschendam
country: Netherlands
facility: Sports medicine department Medical Center The Hague
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: J.A.N. Verhaar, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center The Hague
name: P.L.J. van Veldhoven, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10.