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

NCT03648463 | Withdrawn

• 1 other identifier: IRB-46711
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Integration of the mesenchymal stem cells.

  Number of integrated labeled mesenchymal stem cells in the cartilage regenerate counted from from MRI imaging.

  3 months

Secondary Outcomes (1)

• Knee Injury and Osteoarthritis Outcome Score (pain subscale)

  12 months

Study Arms (2)

arthroscopy with removal of calcified cartilage

EXPERIMENTAL

This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) along with removal of the calcified cartilage layer. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system.

Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection

arthroscopy without removal of calcified cartilage

ACTIVE COMPARATOR

This arm will have patients who will get surgical intervention (menisectomy, synovectomy and debridement) but with retention of the calcified cartilage cap. The patients will also get 5 cc of BMAC produced from The Harvest/Terumo BCT system.

Procedure: arthroscopy of the affected knee/ Bone Marrow Concentrate Injection

Interventions

arthroscopy of the affected knee/ Bone Marrow Concentrate Injection PROCEDURE

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)

Also known as: Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)

arthroscopy with removal of calcified cartilage; arthroscopy without removal of calcified cartilage

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
• Symptomatic knee pain greater than 6 months
• At least one discrete contained chondral defect
• Failed a minimum of 6 weeks of physical therapy
• Grossly normal knee alignment: \<5 degrees of varus or valgus alignment
• Lesion located on medial or lateral femoral condyle or trochlea

You may not qualify if:

• Radiographs demonstrating either no or little osteoarthritis (Kellgren-Lawrence Grade 0 or 1)
• Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
• Malalignment of mechanical axis \> or = 5 degrees of varus/valgus
• Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
• Ligamentous knee instability
• The subject is on ongoing specific osteoarthritis drugs such as chondroitin sulphate, diacerein, N-glucosamine, piascledine, capsaicin in the 2 weeks prior to baseline treatment
• BMI \> 30
• Currently pregnant or planning to become pregnant (no MRI possible).

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lawrence Enweze, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will not know if they received the surgical intervention that entails removing of the calcified cartilage or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 29, 2022

Record last verified: 2022-08