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IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
D.B.F. Saris, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02037204
First received: January 13, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation (ACI) has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a need for improvement. A new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. These chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage lesions of the knee.


Condition Intervention Phase
Foreign-Body Reaction
Inflammation
Effusion (L) Knee
Knee Pain Swelling
Other: Cartilage repair surgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT): Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Safety [ Time Frame: Multiple time points up to 18 months ] [ Designated as safety issue: Yes ]
    Adverse event rate non-inferior to standard treatment (autologous chondrocyte implantation) and leads to no serious adverse events such as a immunological response.


Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical improvement as measured by patient reported outcome scores.


Other Outcome Measures:
  • Structural repair [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.

  • Health care use and costs [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.


Estimated Enrollment: 35
Study Start Date: March 2013
Estimated Study Completion Date: August 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cartilage repair surgery
Single-stage cartilage repair surgery using autologous chondrons and allogeneic MSCs in a fibrin glue carrier.
Other: Cartilage repair surgery
Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
Other Names:
  • Single-stage
  • Cartilage repair
  • IMPACT

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 and <45 years old
  • Symptomatic isolated full-thickness articular cartilage lesion on the femoral condyle or trochlea.
  • Size 2 - 8 cm2
  • Intact anterior cruciate ligament

Exclusion Criteria:

  • (History of) osteoarthritis, defined as Kellgren-Lawrence grade >3 as determined from appropriate X-ray.
  • Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)
  • (History of) Septic arthritis.
  • Malalignment requiring an osteotomy.
  • (History of) total menisectomy in the target knee joint.
  • Any surgery in the knee joint 6 months prior to study inclusion.
  • Risk groups for MRI scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.
  • Patients with severe anxiety for MRI scans and/or needles
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037204

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA
Sponsors and Collaborators
UMC Utrecht
Investigators
Study Director: Tommy S. de Windt, MD UMC Utrecht
Principal Investigator: Daniel B.F. Saris, MD, PhD UMC Utrecht
  More Information

Additional Information:
Publications:
Responsible Party: D.B.F. Saris, MD, PhD, Orthopaedic surgeon, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02037204     History of Changes
Other Study ID Numbers: IMPACT
Study First Received: January 13, 2014
Last Updated: July 17, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
IMPACT
Chondrons
Mesenchymal stem cells
Allogeneic MSCs
single-stage
Cartilage repair
Safety
Efficacy

Additional relevant MeSH terms:
Foreign Bodies
Foreign-Body Reaction
Inflammation
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014