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Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions

NCT03648463 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-29

No results posted yet for this study

Summary

The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored.

The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.

Conditions

  • Cartilage Degeneration
  • Rotator Cuff Tear
  • Osteoarthritis, Knee

Interventions

PROCEDURE

arthroscopy of the affected knee/ Bone Marrow Concentrate Injection

Subjects will undergo knee arthroscopy for debridement, menisectomy and synovectomy of the cartilage defects. Subjects will also be injected with bone marrow aspirate concentrated harvested from the pelvis and centrifuged (produced produced using the Harvest/Terumo BCT system)

Sponsors & Collaborators

Principal Investigators

  • Lawrence Enweze, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-12-31
Completion
2020-12-31

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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 NCT03648463 on ClinicalTrials.gov