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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR).