Table 2.

Inclusion and exclusion criteria of subjects with symptomatic, partial-thickness rotator cuff tear enrolled in this pilot study

Inclusion criteria

Males and females 30–75 years of age.

Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion.

Subjects who have not responded to physical therapy treatments for at least six weeks.

Subjects with > 70% passive range of motion.

Diagnosed with > 50% tear to supraspinatus muscle or < 5 mm separation assessed by MRI.

Diagnosed with a partial-thickness rotator cuff tear.

The ability of subjects to give appropriate consent.

Exclusion criteria

Age < 30 or > 75.

Diagnosed with a full-thickness rotator cuff tear.

Insufficient amount of subcutaneous tissue to allow recovery of 50 mL of lipoaspirate.

History of systemic malignant neoplasms within last 5 years.

History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.

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.).

Subjects who are known to be human immunodeficiency virus positive.

Patients who have received a corticosteroid injection in rotator cuff site within last 3 months.

Severe arthrosis of the glenohumeral or acromioclavicular joint.

Irreparable rotator cuff tear (including rotator cuff tear arthropathy).

Fatty atrophy above grade 2 in affected shoulder.

Previous shoulder surgeries in affected shoulder.

Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures.

History of tobacco use within the last 3 months.

Patient is on an active regimen of chemotherapy.

Patients with a documented history of liver disease or an alanine aminotransferase value >400.

Allergy to sodium citrate of any “caine” type of local anesthetic.

Patient is pregnant or breast feeding.

Subject is, in the opinion of the investigator or designee, unable to comply with the requirements of this pilot study protocol or is unsuitable for this pilot study for any reason. This includes completion of Patient Reported Outcome instruments.

Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

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.

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.