Using autologous cell therapy to treat shoulder osteoarthritis pain and inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of autologous regenerative cell therapy for patients suffering from pain and inflammation due to osteoarthritis of the shoulder. A total of 50 patients will receive treatment involving injections of autologous Stromed and Platelet Rich Plasma (PRP) into the affected joints. Patient outcomes will be monitored through various assessments, including laboratory tests for inflammation markers, quality of life questionnaires, and follow-up MRIs over a period of six months. The study is designed to inform a larger follow-up involving 4,000 patients.

Why it matters

Who can join: the full rules

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 shoulder pain with the index side (left or right shoulder).

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, 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. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
   2. Corticosteroid injection at treatment site within 1 month
   3. Consistent use of NSAIDs within 48 hours of procedure.

Where it's running

• 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
• Email: scott.herkes@gmail.com
• Phone: 855-984-8287

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous adipose-derived stem cell injections for knee osteoarthritis

  We’re testing whether injecting a patient’s own fat-derived stem cells into the knee can help people with knee OA feel less pain and move better, compared with a standard hyaluronic acid treatment.

  Recruiting at 3 sites Yonsei University · Incheon and 2 other locations · NCT07901790

• Early wear of a Vitamin E-infused liner in a dual-mobility hip replacement

  This study tests whether a Vitamin E-infused liner in a dual-mobility hip implant wears as little as a conventional liner over two years in adults needing hip replacement.

  Recruiting Phase 4 Uppsala University · Uppsala, Uppsala County · NCT07863557

• Preoperative Music to Ease Anxiety Before Hip or Knee Replacement

  Patients awaiting hip or knee replacement listen to their own music through noise‑canceling headphones to see if it lowers preoperative anxiety.

  Recruiting Columbia University · New York, New York · NCT07845695

• Weight-bearing dangling exercises vs VMOb NMES for knee osteoarthritis

  This study tests whether weighted dangling exercises or VMOb muscle NMES help people with knee osteoarthritis.

  Recruiting University of Lahore · Lahore, Punjab Province · NCT07701174

• Post-op prednisone vs standard steroid regimen after knee or hip replacement

  This study tests a 5-day oral prednisone course after knee or hip replacement to see if pain, swelling, and glucose control are better or different than the usual intraoperative steroid approach.

  Recruiting Phase 4 Columbia University · New York, New York · NCT07630896

• AI-based prediction of five major diseases using integrated health data

  Researchers are testing an AI model to see if they can predict the onset of five major diseases in adults 30–65 by combining medical records with biospecimens and lifestyle data.

  Recruiting Asan Medical Center · Seoul, Seoul Special City · NCT07595718

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.