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 : Unknown

Verified July 2014 by D.B.F. Saris, UMC Utrecht.
Recruitment status was: Active, not recruiting

First Posted : January 15, 2014

Last Update Posted : July 18, 2014

Sponsor:

Information provided by (Responsible Party):

D.B.F. Saris, UMC Utrecht

Study Description

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

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	35 participants
Intervention Model:	Single Group Assignment
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 :	July 2014
Estimated Study Completion Date :	August 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Safety [ Time Frame: Multiple time points up to 18 months ]
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 ]
Clinical improvement as measured by patient reported outcome scores.

Other Outcome Measures:

Structural repair [ Time Frame: 12 months ]
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 ]
To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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


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:

Trials Register of the European Union This link exits the ClinicalTrials.gov site

Publications:

Bekkers JE, Creemers LB, Tsuchida AI, van Rijen MH, Custers RJ, Dhert WJ, Saris DB. One-stage focal cartilage defect treatment with bone marrow mononuclear cells and chondrocytes leads to better macroscopic cartilage regeneration compared to microfracture in goats. Osteoarthritis Cartilage. 2013 Jul;21(7):950-6. doi: 10.1016/j.joca.2013.03.015. Epub 2013 Apr 9.

Bekkers JE, Tsuchida AI, van Rijen MH, Vonk LA, Dhert WJ, Creemers LB, Saris DB. Single-stage cell-based cartilage regeneration using a combination of chondrons and mesenchymal stromal cells: comparison with microfracture. Am J Sports Med. 2013 Sep;41(9):2158-66. doi: 10.1177/0363546513494181. Epub 2013 Jul 5.

Vonk LA, Doulabi BZ, Huang C, Helder MN, Everts V, Bank RA. Preservation of the chondrocyte's pericellular matrix improves cell-induced cartilage formation. J Cell Biochem. 2010 May;110(1):260-71. doi: 10.1002/jcb.22533.


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
Last Update Posted:	July 18, 2014
Last Verified:	July 2014

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:


Inflammation Foreign Bodies Foreign-Body Reaction Pathologic Processes Wounds and Injuries

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