EUCTR2013-000966-12-GBActive, not recruitingPhase 1
Autologous Stem Cells in Achilles Tendinopathy (ASCAT)- A phase II, single centre, proof of concept study - Autologous Stem Cells in Achilles Tendinopathy
niversity College London0 sites10 target enrollmentStarted: January 11, 2019Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Aged equal to or over 18 and equal to or less than 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
- •Females of childbearing age and potential must be willing to use two forms of effective contraception from the time of consent to 6 months post-injection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
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-TNF drugs, methotrexate, or ciprofloxacin (or use within 4 weeks of assessment for eligibility)
- •Positive for HBV, HCV, HIV 1 and 2, syphilis and HTLV
- •Previous AT surgery on the tendon to receive MSC implantation
- •Inflammatory arthritis
- •Known or suspected underlying haematological malignancy
- •Other active malignancy in the past 3 years
- •Bovine or antibiotic allergy
Investigators
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