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Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint

NCT03513731 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-20

No results posted yet for this study

Summary

This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.

Conditions

  • Osteoarthritis of Facet Joint of Lumbar Spine

Interventions

DEVICE

Adipose-derived stem cell injection

ADRC injection into the facet joint

DRUG

Corticosteroid injection

Corticosteroid injection into the facet joint

Sponsors & Collaborators

  • Sanford Health

    collaborator OTHER

  • InGeneron, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2025-12-31
Completion
2026-04-30
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 NCT03513731 on ClinicalTrials.gov