Using patients' own cells to treat osteoarthritis
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
This study is testing whether using patients' own stem cells and platelet-rich plasma can help treat osteoarthritis better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Healeon Medical Inc Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Valencia, California and 1 other locations) |
| Trial ID | NCT04238143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with documented osteoarthritic changes in joints such as the knee, hip, or shoulder, who are able to tolerate the procedures.
Not a fit: Patients with systemic disorders, active cancer, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a long-term, minimally invasive treatment option for patients suffering from osteoarthritis.
How similar studies have performed: Other studies have shown promise with similar biocellular approaches, but this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Valencia, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.