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Clinical Trials in the USA / NCT02844738
Recruiting Phase 2

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

NCT02844738 · tracked via the Priya Life Science USA tracker
Sponsor
VivaTech International, Inc.
Phase
Phase 2
Started
2015-07
Last updated
2025-10-14

Condition(s) studied

Osteoarthritis

Investigational drug(s) / intervention(s)

[StroMed + platelet rich plasma (PRP)]

[StroMed + platelet rich plasma (PRP)]: Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated as direct injections to the joint with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Days 7 and 14 \[PRP\]

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
VivaTech International, Inc. Grove City Pennsylvania Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02844738 on ClinicalTrials.gov ↗ ← All trials in the USA