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

VivaTech International, Inc. · NCT02844751

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
4000
US sites recruiting
1
Study start
July 2015
Record last updated
October 14, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: [StroMed + platelet rich plasma (PRP)]; [PRP] platelet rich plasma; [PRP] platelet rich plasma

Conditions: Osteoarthritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Recruiting US locations

  • VivaTech International, Inc.

    Grove City, PA 16127

    Site contact: Scott M Herkes, MBA · 855-984-8287 · scott.herkes@gmail.com

Study contacts (from the official record)

  • Scott M Herkes, MBA · 855-984-8287 · scott.herkes@gmail.com
  • Michael P Hutchinson, DVM · 412-503-3788 · drmike@vivatechusa.com
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Safety & Effectiveness of Autologous Regenerative Cell Therapy on… (NCT02844751) | Bored Studies