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

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ClinicalTrials.gov Identifier: NCT02037204
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : January 1, 2019
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
D.B.F. Saris, UMC Utrecht

Brief Summary:
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 or disease Intervention/treatment Phase
Foreign-Body Reaction Inflammation Effusion (L) Knee Knee Pain Swelling Other: Cartilage repair surgery Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: First in man surgery: autologous chondrons are mixed with allogeneic MSCs and implanted in a fibrin glue carrier in a one-stage surgical procedure.
Masking: None (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.
Study Start Date : March 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Cartilage repair surgery
Single-stage cartilage repair surgery using autologous chondrons (10-20%) and allogeneic MSCs (80-90%) in a fibrin glue carrier with a dosage of two million cells/ cm2 applied once during a surgical procedure.
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




Primary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: 18 months ]
    Adverse events rate


Secondary Outcome Measures :
  1. Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 3 and 18 months ]
    Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.


Other Outcome Measures:
  1. Structural Repair [ Time Frame: 12 months ]
    To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.

  2. Health Care Use and Costs [ Time Frame: 18 months ]
    To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037204


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

Additional Information:
Publications:
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Responsible Party: D.B.F. Saris, MD, PhD, Orthopaedic surgeon, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02037204     History of Changes
Other Study ID Numbers: IMPACT
First Posted: January 15, 2014    Key Record Dates
Results First Posted: January 1, 2019
Last Update Posted: January 1, 2019
Last Verified: June 2018
Keywords provided by D.B.F. Saris, UMC Utrecht:
IMPACT
Chondrons
Mesenchymal stem cells
Allogeneic MSCs
single-stage
Cartilage repair
Safety
Efficacy
Additional relevant MeSH terms:
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Inflammation
Foreign-Body Reaction
Foreign Bodies
Pathologic Processes
Wounds and Injuries