NCT04238143Recruiting
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 13 Jan 2020
- Start date
- 10 Jan 2020
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Healeon Medical Inc
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04238143
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 10 Jan 2020 to the primary completion date, 30 Sept 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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;
Other illness
- 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;
- Active infections which would increase risk of patient to undergo treatment;
- 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
Other
- Pregnancy;
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regenevita LLC Coordinator of this site? Confirm its status | Stevensville | United States | Not yet recruiting |
| Hemwall Center for Orthopedic Regenerative Medicine Coordinator of this site? Confirm its status | Valencia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.