Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip
VivaTech International, Inc.
4,000 participants
Jul 1, 2015
INTERVENTIONAL
Conditions
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 hip. Follow-up will consist of a larger sample including 4,000 patients.
Eligibility
Inclusion Criteria8
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 18-90 years of age.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- Patients with adequate cardiac and respiratory function.
- Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
- Patients must have adequate immune system function, with no known immunodeficiency disease.
- Greater than 6 months hip pain with the index side (left or right).
Exclusion Criteria11
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
- Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) > 40kg/m2
- Presence of active infection.
- 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.
- Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
- Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip osteoarthritis
- Corticosteroid injection at treatment site within 1 month
- Consistent use of NSAIDs within 48 hours of procedure.
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Interventions
Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) 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 with direct injections to the joint with Platelet Rich Plasma processed by RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Day 7, 14 and 30 \[PRP\]
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02844764