Thinking of joining a study?

Register your interest

Become a volunteer?

NCT02844764 | RECRUITING | Osteoarthritis

Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
Sponsor:

VivaTech International, Inc.

Brief 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.

Condition or disease

Osteoarthritis

Intervention/treatment

[StroMed + platelet rich plasma (PRP)]

Phase

PHASE2

Detailed Description:

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. Patients will be treated for Osteoarthritis (OA) of the hip 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 the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, hip disability and osteoarthritis outcome score (HOOS) questionnaires and follow up MRI's at various endpoints to 6 months. 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 hip replacement therapy.

Study Type : INTERVENTIONAL
Estimated Enrollment : 4000 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip
Actual Study Start Date : 2015-07
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Patients with indication of Osteoarthritis. 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 hip pain with the index side (left or right).
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
    • * 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.
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip

Location Details

NCT02844764

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

VivaTech International, Inc.

Grove City, Pennsylvania, United States, 16127