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Autologous Stem Cells in Achilles Tendinopathy (ASCAT)

This study is currently recruiting participants.
Verified May 2016 by University College, London
Sponsor:
ClinicalTrials.gov Identifier:
NCT02064062
First Posted: February 17, 2014
Last Update Posted: May 12, 2016
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.
Information provided by (Responsible Party):
University College, London
  Purpose
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.

Condition Intervention Phase
Achilles Tendinitis, Right Leg Achilles Tendinitis Achilles Degeneration Achilles Tendon Thickening Tendinopathy Achilles Tendinitis, Left Leg Biological: Autologous Mesenchymal Stem Cells Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cells in Achilles Tendinopathy

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: January 2015
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Mesenchymal Stem Cells Biological: Autologous Mesenchymal Stem Cells
Other Names:
  • Mesenchymal Stem Cells
  • Stromal Cells
  • Stem Cells
  • Cell Therapy

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥18 and ≤ 70 (both males and females)
  • Participants with chronic midportion AT (as defined by pain in region of AT and tender swelling in mid portion of AT (no tenderness over bony attachment to heel) with symptoms for longer than 6 months who have failed conservative treatment (at least a full course of physiotherapy) and for whom surgery is being considered
  • Able to provide written informed consent

Exclusion Criteria:

  • Previous bony surgery (e.g. reconstructive pelvic osteotomy) at or in proximity to the bone marrow harvest site
  • Pregnancy or lactation
  • Current use of steroids, anti-tumour necrosis factor (TNF) drugs, methotrexate, or ciprofloxacin (or use within 4 weeks of assessment for eligibility)
  • Positive for hepatitis B virus (HBV), Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV 1 and 2), syphilis and human t-cell leukaemia virus (HTLV)
  • Previous AT surgery on the tendon to receive mesenchymal stem cell (MSC) implantation
  • Inflammatory arthritis
  • Known or suspected underlying haematological malignancy
  • Other active malignancy in the past 3 years
  • Bovine or antibiotic allergy
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Andy Goldberg 0208 909 5825 andy.goldberg@rnoh.nhs.uk

Locations
United Kingdom
Royal National Orthopaedic Hospital Recruiting
London, United Kingdom, HA74LP
Principal Investigator: Andrew Goldberg         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Andrew Goldberg, MBBS MD FRCSI FRCS(Tr&Orth) Royal National Orthopaedic Hospital NHS Trust, UCL
  More Information

Additional Information:
Publications:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02064062     History of Changes
Other Study ID Numbers: 12/0419
2013-000966-12 ( EudraCT Number )
First Submitted: February 12, 2014
First Posted: February 17, 2014
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University College, London:
Achilles Tendinopathy
Autologous Stem Cells
Musculoskeletal

Additional relevant MeSH terms:
Tendinopathy
Bursitis
Exostoses
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Joint Diseases
Hyperostosis
Bone Diseases