What this study is
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 knee. Follow-up will consist of a larger sample including 4,000 patients.
What's being tested
- [StroMed + platelet rich plasma (PRP)]
Intervention · BIOLOGICAL
[Day 0] - Because no enzymes or drugs are added with this mechanical process, the resulting cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Also Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint.
- [PRP] platelet rich plasma
Intervention · BIOLOGICAL
Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 7,14 and 30
- [PRP] platelet rich plasma
Intervention · BIOLOGICAL
Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 30 and 60
Study details
- Official title
- Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee
- Sponsor
- VivaTech International, Inc.
- Conditions
- Osteoarthritis
- Enrolling
- 4,000 people
- Starts
- 2015-07
- Est. completion
- 2026-08
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Patients with indication of Osteoarthritis, grade 2 or more. 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 knee pain on the index side (left or right knee).
You can't join if
- 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:; Knee instability.; A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.; Gout or pseudo gout; Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis; Corticosteroid injection at treatment site within 1 month; Consistent use of NSAIDs within 48 hours of procedure.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVivaTech International, Inc.
Grove City, Pennsylvania, United States
- Scott M Herkes, MBA · Contact855-984-8287scott.herkes@gmail.com
- Michael P Hutchinson, DVM · Contact412-503-3788drmike@vivatechusa.com
- Mark LoDico, MD · Principal investigator
Recruiting
Study team
Sponsor
VivaTech International, Inc.
Study ID IRCM-2016-112
Principal investigator
Mark LoDico, MD
Advanced Regenerative Medicine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.