NCT04238143 - Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

January 10, 2020

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions

OsteoarthritisOsteo Arthritis KneeOsteo Arthritis ShouldersOsteoarthritis of Multiple JointsOsteoarthritis, HipOsteoarthritis - Ankle/Foot

Interventions

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 1

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 1

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Tissue Stromal Vascular Fraction (tSVF) Arm 2

Harvesting subcutaneous tSVF with sterile, disposable microcannula system

BIOLOGICAL

PRP Concentrate Arm 2

Preparation of PRP Concentrate via sterile Terumo-Harvest System

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 2

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

PROCEDURE

Cellular Stromal Vascular Fraction (cSVF) Arm 3

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

DRUG

Sterile Normal Saline (IV Solution)

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

Trial Locations (2)

NOT_YET_RECRUITING

Regenevita LLC, Stevensville

RECRUITING

Hemwall Center for Orthopedic Regenerative Medicine, Valencia