Autologous Stem Cells in Achilles Tendinopathy

NCT ID: NCT02064062

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

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.

Conditions

Achilles Tendinitis, Right Leg; Achilles Tendinitis; Achilles Degeneration; Achilles Tendon Thickening; Tendinopathy; Achilles Tendinitis, Left Leg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Mesenchymal Stem Cells

Group Type: EXPERIMENTAL

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Interventions

Autologous Mesenchymal Stem Cells

Intervention Type: BIOLOGICAL

Other Intervention Names

Mesenchymal Stem Cells; Stromal Cells; Stem Cells; Cell Therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Royal National Orthopaedic Hospital NHS Trust, UCL

Locations

Royal National Orthopaedic Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Andy Goldberg

Role: CONTACT

andy.goldberg@rnoh.nhs.uk

0208 909 5825

References

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.

Reference Type: BACKGROUND

PMID: 12553472 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29764889 (View on PubMed)

Related Links

http://www.ucl.ac.uk/jro/academic-clinical-trials/advanced-therapies

Related Info

Other Identifiers

2013-000966-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12/0419

Identifier Type: -

Identifier Source: org_study_id