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Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

NCT ID: NCT04238143
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Healeon Medical Inc
Conditions: Osteo Arthritis Knee, Osteo Arthritis Shoulders, Osteoarthritis, Osteoarthritis - Ankle/Foot, Osteoarthritis of Multiple Joints, Osteoarthritis, Hip

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain

Enrollment: 100 participants (Estimated).

What is being studied

Intervention: Administration, Intravenous
Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 2
Procedure: Cellular Stromal Vascular Fraction (cSVF) Arm 3
Intervention: Drug Administration Routes
Intervention: Drug Therapy
Intervention: Infusions, Intravenous
Intervention: Infusions, Parenteral
Biological: PRP Concentrate Arm 1
Biological: PRP Concentrate Arm 2
Drug: Sterile Normal Saline (IV Solution)
Intervention: Therapeutics
Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 1
Procedure: Tissue Stromal Vascular Fraction (tSVF) Arm 2

Who may be eligible

Ages: 18 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 1 is listed as Recruiting.

Countries: United States

California, United States: 1
Montana, United States: 1

Sample of listed locations

Hemwall Center for Orthopedic Regenerative Medicine — Valencia, California, 91355, United States — Recruiting
Regenevita LLC — Stevensville, Montana, 59870, United States — Not yet recruiting

Study details

Start date: January 10, 2020
Primary completion date: September 30, 2026
Completion date: September 30, 2027
First posted: January 23, 2020
Collaborators: Donna Alderman, DO, Robert W. Alexander, MD

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04238143
Registry last updated: October 1, 2024
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT04238143 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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