Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Recruiting now · Not applicable
Conditions studied: Osteoarthritis, Osteo Arthritis Knee, Osteo Arthritis Shoulders, Osteoarthritis of Multiple Joints, Osteoarthritis, Hip, Osteoarthritis - Ankle/Foot
In brief
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.
Key facts
- Study ID
- NCT04238143
- Run by
- Healeon Medical Inc
- People needed
- 100
- Starts
- 2020-01-10
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Hemwall Center for Orthopedic Regenerative Medicine — Valencia, California, United States (enrolling)
- Regenevita LLC — Stevensville, Montana, United States
Full record on ClinicalTrials.gov
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