NCT04238143 Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
| NCT ID | NCT04238143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Healeon Medical Inc |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-01-10 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-01-10 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04238143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04238143 currently recruiting?
Yes, NCT04238143 is actively recruiting participants. Contact the research team at hemwallcenter@prolotherapy.com for enrollment information.
Where is the NCT04238143 trial being conducted?
This trial is being conducted at Valencia, United States, Stevensville, United States.
Who is sponsoring the NCT04238143 clinical trial?
NCT04238143 is sponsored by Healeon Medical Inc. The trial plans to enroll 100 participants.