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 个研究点目标入组 10 人开始时间: 2019年1月11日最近更新: 2019年2月28日

试验速览

暂无简介。

•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

•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

发起方

niversity College London