Using autologous cell therapy to treat knee osteoarthritis pain and inflammation

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

This study is testing if a new cell therapy using your own body’s cells can help relieve pain and swelling in people with knee osteoarthritis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 4000 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: VivaTech International, Inc. (industry)
• Locations: 1 site (Grove City, Pennsylvania)
• Trial ID: NCT02844751 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of autologous regenerative cell therapy for patients suffering from knee osteoarthritis. It involves a prospective open-label design with an initial cohort of 50 patients receiving injections of autologous Stromed and Platelet Rich Plasma (PRP) to alleviate pain and inflammation. Patient outcomes will be monitored through MRI scans, laboratory tests for inflammation markers, and various questionnaires assessing knee function and quality of life over a follow-up period of up to 6 months. The study will eventually expand to include a larger sample size of 4,000 patients for further validation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with grade 2 or higher osteoarthritis of the knee and a history of knee pain for over 6 months.

Not a fit: Patients with recent cancer diagnoses, significant cardiovascular issues, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce pain and inflammation in patients with knee osteoarthritis, potentially delaying the need for knee replacement surgery.

How similar studies have performed: While the use of autologous cell therapies is gaining traction, this specific approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

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