Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Launched by UNIVERSITY OF SOUTHERN DENMARK · Jul 10, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Damage to the tendons that stabilize the shoulder, particularly the supraspinatus tendon tear, has been recognized as the key lesion in rotator cuff tears. However, the lack of full functional recovery after surgical tendon reconstruction suggests that additional changes in the tissue are obstacles to rehabilitation. Recent studies demonstrate pathological changes in the supraspinatus muscle in animal models as a consequence of tendon tear. The muscle pathology includes muscle fibre atrophy, intracellular lipid accumulation, mitochondrial dysfunction, fibril disorganization, and reduced reg...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Clinical signs and symptoms compatible with a traumatic RCT
- • MR verified supraspinatus tear
- • Reparable lesion with tendon retraction \< 2 cm.
- • Fatty infiltration level 0-2 (out of 5) according to Fuchs et al. and based on Goutalliers classification
- • No history of inflammatory disease
- • ASA score \< 3 (patients in good health)
- • Signed consent to the study (including use of relevant data from the patient's electronic health records)
- • Exclusion Criteria
- • No MRI of the shoulder
- • Former surgery in the affected shoulder
- • Signs of infection
- • Immunosuppression (due to clinical condition or medical therapy)
- • History of inflammatory disease
- • Malignancy within 5 years
- • Previous radiotherapy to the shoulder
- • BMI under 18
- • BMI above 35
- • Coagulopathy
- • Non-Danish speaking patients
About University Of Southern Denmark
The University of Southern Denmark (SDU) is a prominent research institution dedicated to advancing knowledge and innovation across various fields, including health sciences. As a clinical trial sponsor, SDU is committed to conducting rigorous and ethically sound research aimed at improving patient outcomes and informing clinical practices. Leveraging its multidisciplinary expertise and state-of-the-art facilities, SDU collaborates with healthcare professionals, industry partners, and regulatory bodies to develop and execute clinical trials that adhere to the highest standards of scientific integrity and compliance. Through its research initiatives, SDU seeks to contribute to the global body of medical knowledge and enhance the quality of healthcare delivery.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sønderborg, Danmark, Denmark
Patients applied
Trial Officials
Lars H. Frick, Prof.
Principal Investigator
University of Hospital of Southern Denmark - Aabenraa
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported