Using patients' own cells to treat osteoarthritis

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 study investigates the use of autologous stem/stromal cells combined with high-dose platelet-rich plasma (HD-PRP) to treat osteoarthritis (OA) through minimally invasive methods. It aims to address the limitations of traditional surgical interventions and medical management by employing biocellular and cellular therapies. Participants will undergo various treatment approaches, including guided biocellular therapy and systemic deployment of cellular stromal vascular fraction (cSVF), with their progress tracked over time. The study will document baseline findings and evaluate the safety and effectiveness of these innovative treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR);
* No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;
* Have the ability to understand and accept all items in Informed Consent Document;
* Have adequate perivascular and extracellular matrix donor tissues available;
* Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities

Exclusion Criteria:

* Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
* Known active cancer, chemotherapy, or radiation therapy;
* Pregnancy;
* Active infections which would increase risk of patient to undergo treatment;
* High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
* Medication or Opiate addition, or in active treatment for drug rehabilitation;
* History of documented severe traumatic brain injuries;
* In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements

Where it's running

• Hemwall Center for Orthopedic Regenerative Medicine
  Valencia, California, United States Recruiting
• Regenevita LLC
  Stevensville, Montana, United States Not yet recruiting

Study contacts

• Study coordinator: Donna Alderman, DO
• Email: hemwallcenter@prolotherapy.com
• Phone: 1 661 295 1110

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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.