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Autologous Stem Cells in Achilles Tendinopathy (ASCAT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University College, London
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT02064062
First received: February 12, 2014
Last updated: February 13, 2014
Last verified: February 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ultrasound Tissue Characterisation (UTC) changes from baseline [ Time Frame: Baseline immediately before implantation and at weeks 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Inter-observer reliability of UTC against conventional US [ Time Frame: Baseline immediately before implantation and at weeks 6, 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2014
Estimated Primary Completion Date: May 2016 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064062

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

Locations
United Kingdom
Royal National Orthopaedic Hospital Not yet 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
Study First Received: February 12, 2014
Last Updated: February 13, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014