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Recruiting Phase 2

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

NCT02844751 · tracked via the Priya Life Science USA tracker
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)]All [StroMed trials (3) →All Platelet rich plasma (PRP)] trials (4) →[PRP] platelet rich plasma[PRP] platelet rich plasma

[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

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 knee. 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, grade 2 or more. 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 knee pain on the index side (left or right knee). 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 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.

Primary outcome measure(s)

  • Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score) — 0, 2, 6 months
    Knee osteoarthritis outcome score

Trial sites (1)

FacilityCityRegionStatus
VivaTech International, Inc. Grove City Pennsylvania Recruiting
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 NCT02844751 on ClinicalTrials.gov ↗ ← All trials in the USA