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Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder

RecruitingPhase 2Healthy volunteers welcome

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Shoulder

Who can join

Ages 18 to 90 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
5. Patients with adequate cardiac and respiratory function.
6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
7. Patients must have adequate immune system function, with no known immunodeficiency disease.
8. Greater than 6 months shoulder pain with the index side (left or right shoulder).

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) \> 40kg/m2
6. Presence of active infection.
7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:

   1. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
   2. Corticosteroid injection at treatment site within 1 month
   3. Consistent use of NSAIDs within 48 hours of procedure.

About the study

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000 patients.

What is being tested

Sponsor: VivaTech International, Inc. · Participants: 4,000 · Started: 2015-07

Contact the study team

Official record on ClinicalTrials.gov — NCT02844738

Locations in the U.S.

PennsylvaniaVivaTech International, Inc., Grove City

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.