NCT02064062

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

February 12, 2014

Last Update Submit

May 11, 2016

Conditions

Achilles Tendinitis, Right LegAchilles TendinitisAchilles DegenerationAchilles Tendon ThickeningTendinopathyAchilles Tendinitis, Left Leg

Keywords

Achilles TendinopathyAutologous Stem CellsMusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR).

    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.

    6 months

Secondary Outcomes (4)

  • Incidence of success

    6 months

  • Conventional ultrasound changes from baseline

    Baseline immediately before implantation and at weeks 6, 12 and 24

  • Ultrasound Tissue Characterisation (UTC) changes from baseline

    Baseline immediately before implantation and at weeks 6, 12 and 24

  • Inter-observer reliability of UTC against conventional US

    Baseline immediately before implantation and at weeks 6, 12 and 24

Study Arms (1)

Autologous Mesenchymal Stem Cells

EXPERIMENTAL
Biological: Autologous Mesenchymal Stem Cells

Interventions

Autologous Mesenchymal Stem CellsBIOLOGICAL
Also known as: Mesenchymal Stem Cells, Stromal Cells, Stem Cells, Cell Therapy
Autologous Mesenchymal Stem Cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Orthopaedic Hospital

London, HA74LP, United Kingdom

RECRUITING

Related Publications (2)

  • Smith RK, Korda M, Blunn GW, Goodship AE. Isolation and implantation of autologous equine mesenchymal stem cells from bone marrow into the superficial digital flexor tendon as a potential novel treatment. Equine Vet J. 2003 Jan;35(1):99-102. doi: 10.2746/042516403775467388. No abstract available.

    PMID: 12553472BACKGROUND

  • Goldberg AJ, Zaidi R, Brooking D, Kim L, Korda M, Masci L, Green R, O'Donnell P, Smith R. Autologous Stem Cells in Achilles Tendinopathy (ASCAT): protocol for a phase IIA, single-centre, proof-of-concept study. BMJ Open. 2018 May 14;8(5):e021600. doi: 10.1136/bmjopen-2018-021600.

    PMID: 29764889DERIVED

Related Links

MeSH Terms

Conditions

Tendinopathy

Interventions

SLC25A33 protein, humanCell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Andrew Goldberg, MBBS MD FRCSI FRCS(Tr&Orth)

    Royal National Orthopaedic Hospital NHS Trust, UCL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Goldberg

CONTACT

0208 909 5825andy.goldberg@rnoh.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

GB(1)