Autologous Stem Cells in Achilles Tendinopathy (ASCAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02064062|
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendinitis, Right Leg Achilles Tendinitis Achilles Degeneration Achilles Tendon Thickening Tendinopathy Achilles Tendinitis, Left Leg||Biological: Autologous Mesenchymal Stem Cells||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Stem Cells in Achilles Tendinopathy|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Experimental: Autologous Mesenchymal Stem Cells||
Biological: Autologous Mesenchymal Stem Cells
- The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR). [ Time Frame: 6 months ]The primary safety outcome is the incidence rate of SARs. This will be expressed as the proportion of participants experiencing a SAR at any time over the 24 week follow-up period. Primary outcomes will be assessed by adverse events reporting, clinical assessment and ultrasound.
- Incidence of success [ Time Frame: 6 months ]The secondary efficacy outcome measure is the incidence of success at 6 months, where success is defined as a reduction of 2 or more points on VAS of pain and an increase of VISA-A score greater than the Minimum Clinically Important Difference (MCID).
- Conventional ultrasound changes from baseline [ Time Frame: Baseline immediately before implantation and at weeks 6, 12 and 24 ]
- Ultrasound Tissue Characterisation (UTC) changes from baseline [ Time Frame: Baseline immediately before implantation and at weeks 6, 12 and 24 ]
- Inter-observer reliability of UTC against conventional US [ Time Frame: Baseline immediately before implantation and at weeks 6, 12 and 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064062
|Contact: Andy Goldberg||0208 909 firstname.lastname@example.org|
|Royal National Orthopaedic Hospital||Recruiting|
|London, United Kingdom, HA74LP|
|Principal Investigator: Andrew Goldberg|
|Principal Investigator:||Andrew Goldberg, MBBS MD FRCSI FRCS(Tr&Orth)||Royal National Orthopaedic Hospital NHS Trust, UCL|