Using patients' own cells to treat hip osteoarthritis pain and inflammation

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip

This study is testing whether using patients' own cells in injections can help reduce pain and inflammation in people with hip osteoarthritis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4000 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: VivaTech International, Inc. (Industry-sponsored)
• Locations: 1 site (Grove City, Pennsylvania)
• Trial ID: NCT02844764 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective open-label study involving 50 patients aimed at assessing the safety and effectiveness of autologous regenerative cell therapy for treating pain and inflammation associated with osteoarthritis of the hip. Patients will receive injections of autologous Stromed and Platelet Rich Plasma (PRP) directly into the affected joints. Outcomes will be evaluated through laboratory tests, hip disability and osteoarthritis outcome scores, quality of life measures, and follow-up MRIs over a period of six months. The study aims to gather data that could lead to a larger follow-up involving 4,000 patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with a diagnosis of osteoarthritis of the hip and chronic pain lasting more than six months.

Not a fit: Patients with recent cancer diagnoses, significant cardiovascular issues, or certain infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and inflammation for patients suffering from hip osteoarthritis, potentially delaying the need for hip replacement surgery.

How similar studies have performed: While this approach is innovative, similar studies using autologous cell therapies have shown promise in treating various conditions, indicating potential for success.

Eligibility 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.

Where this trial is running

Grove City, Pennsylvania

• VivaTech International, Inc. — Grove City, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Mark LoDico, MD — Advanced Regenerative Medicine
• Study coordinator: Scott M Herkes, MBA

Conditions Osteoarthritis