Stem cells to treat diseased tendo

Phase 1

• Conditions: The Achilles tendon is the largest tendon in the body and it plays an important role in the biomechanics of the lower extremity.The disease to be studied in the trial is Achilles tendinopathy (AT). Achilles Tendinopathy a degenerative process that leads to pain and dysfunction in middle-aged individuals and sports participants.; MedDRA version: 20.0 Level: LLT Classification code 10000435 Term: Achilles tendon injury System Organ Class: 100000004863; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-000966-12-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified