RecruitingNot ApplicableNCT04238143

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

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


Sponsor

Healeon Medical Inc

Enrollment

100 participants

Start Date

Jan 10, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment that uses the patient's own fat tissue (adipose-derived cells and support matrix) to help heal damaged joints and connective tissues — such as knee, hip, shoulder, ankle, or plantar fasciitis — caused by osteoarthritis or injury. **You may be eligible if...** - You have documented osteoarthritis or degenerative joint changes in the knee, hip, shoulder, ankle, wrist, foot, Achilles tendon, sacroiliac joint, or plantar fascia - You are healthy enough to safely undergo the procedure - You have enough donor tissue available - You are able to understand and follow the study requirements and post-treatment tracking **You may NOT be eligible if...** - You have active cancer, or are currently receiving chemotherapy or radiation - You are pregnant - You have active infections - You have used high-dose steroids or received corticosteroids within 6 months before treatment - You have a history of severe traumatic brain injury - You have drug or opioid addiction or are in active rehabilitation for substance use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETissue Stromal Vascular Fraction (tSVF) Arm 1

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICALPRP Concentrate Arm 1

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURETissue Stromal Vascular Fraction (tSVF) Arm 2

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICALPRP Concentrate Arm 2

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURECellular Stromal Vascular Fraction (cSVF) Arm 2

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

PROCEDURECellular Stromal Vascular Fraction (cSVF) Arm 3

Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

DRUGSterile Normal Saline (IV Solution)

Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)


Locations(2)

Hemwall Center for Orthopedic Regenerative Medicine

Valencia, California, United States

Regenevita LLC

Stevensville, Montana, United States

View Full Details on ClinicalTrials.gov

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NCT04238143


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