| Eligibility |
Inclusion Criteria:
1. Males and females 30-75 years of age.
2. Clinical symptoms consistent with a rotator cuff lesion including but not limited to
pain, muscle weakness, or active-limited range of motion (AROM).
3. Subjects who have not responded to physical therapy treatments for at least six weeks.
4. Subjects with > 70% passive range of motion (PROM).
5. Diagnosed with >50% tear to supraspinatus muscle or < 5mm separation assessed by MRI.
6. Diagnosed with a partial-thickness rotator cuff tear
7. The ability of subjects to give appropriate consent or have an appropriate
representative available.
Exclusion Criteria:
1. Age <30 or > 75
2. Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
3. History of systemic malignant neoplasms within last 5 years.
4. History of local neoplasm within the last 6 months and any history of local neoplasm
at site of administration.
5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or
severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human
immunodeficiency virus, systemic lupus erythematosus, etc.).
6. Subjects who are known to be HIV positive
7. Patients who have received a corticosteroid injection in rotator cuff site within last
3 months
8. Severe arthrosis of the glenohumeral or acromioclavicular joint
9. Irreparable rotator cuff tear (including rotator cuff tear arthropathy)
10. Fatty atrophy above Grade 2 in affected shoulder
11. Previous shoulder surgeries in affected shoulder
12. History of tobacco use within the last 3 months
13. Any contraindications to MRI scan according to MRI guidelines, or unwillingness to
undergo MRI procedures
14. Patients on an active regimen of chemotherapy
15. Patients with a documented history of liver disease or an ALT value >400
16. Allergy to sodium citrate of any "caine" type of local anesthetic
17. Patients pregnant or breast feeding
18. Subject is in the opinion of the Investigator or designee, unable to comply with the
requirements of the study protocol or is unsuitable for the study for any reason. This
includes completion of Patient Reported Outcome instruments.
19. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.
20. Subject is part of a vulnerable population who, in the judgment of the investigator,
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include: Individuals with mental
disability, persons in nursing homes, children, impoverished persons, persons in
emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention.
21. Uncooperative patients or those with neurological/psychiatric disorders who are
incapable of following directions or who are predictably unwilling to return for
follow-up examinations.
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