💬In plain words
What the trial is, and whether it could suit you
Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures.
This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Tissue Stromal Vascular Fraction (tSVF) Arm 1
- PRP Concentrate Arm 1
- Tissue Stromal Vascular Fraction (tSVF) Arm 2
- PRP Concentrate Arm 2
- Cellular Stromal Vascular Fraction (cSVF) Arm 2
Hemwall Center for Orthopedic Regenerative Medicine
Valencia, United States
Regenevita LLC
Stevensville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky