Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
NCT ID: NCT02844751
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
4000 participants
INTERVENTIONAL
2015-07-31
2026-08-31
Brief Summary
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Detailed Description
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Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints.
Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month.
Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months.
Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending knee replacement therapy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Interventions assigned by Principal Investigator
[StroMed + platelet rich plasma (PRP)]
\[Day 0\] - 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
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
Cohort 2
Interventions assigned by Principal Investigator
[StroMed + platelet rich plasma (PRP)]
\[Day 0\] - 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
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
Interventions
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[StroMed + platelet rich plasma (PRP)]
\[Day 0\] - 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
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
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
Eligibility Criteria
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Inclusion Criteria
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 knee pain on the index side (left or right knee).
Exclusion Criteria
2. Presence of clinically significant acute or unstable cardiovascular and 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. Knee instability.
2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
3. Gout or pseudo gout
4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis
5. Corticosteroid injection at treatment site within 1 month
6. Consistent use of NSAIDs within 48 hours of procedure.
18 Years
90 Years
ALL
Yes
Sponsors
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VivaTech International, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark LoDico, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Regenerative Medicine
Locations
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VivaTech International, Inc.
Grove City, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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website for VivaTech
Other Identifiers
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IRCM-2016-112
Identifier Type: -
Identifier Source: org_study_id
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