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Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

NCT04440189 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-04-23

No results posted yet for this study

Summary

This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

GID SVF-2 Device System

The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.

Sponsors & Collaborators

  • GID BIO, Inc.

    lead INDUSTRY

Principal Investigators

  • William Cimino, PhD · GID BIO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2024-12-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440189 on ClinicalTrials.gov