A Phase 3 interventional study of Instant MSC Product accompanying Autologous Chondron Transplantation in Cartilage Damage, sponsored by R.J.H. Custers. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by R.J.H. Custers · Phase 3, Interventional, and Treatment
Articular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation 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. 'Instant MSC Product accompanying Autologous Chondron Transplantation' (IMPACT) combines autologous recycled chondrons (chondrocytes surrounded by pericellular matrix) with MSCs for one-stage treatment of cartilage defects. IMPACT was successfully executed in a first-in-man phase I/II clinical trial in which 35 participants with cartilage defects were treated. The results showed a good safety profile, proper feasibility and good initial clinical efficacy at 18 months follow-up. Also good outcome at 24 and 36 months was shown in ongoing post study surveying of the participants. Consequently a new study with IMPACT was designed; IMPACT2. The objective of IMPACT2 is to compare clinical outcomes of 30 individual participants with cartilage defects treated with IMPACT to 30 participants treated with standard care for 9 months (consisting of optional physical therapy and pain medication). Participants should be aged 18-45 years with a symptomatic Modified Outerbridge Grade III or IV cartilage lesion of the knee ranging in size 2-8 cm\^2.
After enrolment, participants will be allocated (randomized) to either group A in which case they receive IMPACT-treatment, or group B that will receive standard care. Standard care consists of optional physical therapy and pain medication. After 9 months, participants in group B can receive the IMPACT-procedure as well.
IMPACT is designed as a one-stage cell-based regenerative therapy for isolated articular cartilage lesions. The investigational product consists of two cell types. Firstly, allogeneic MSCs, which are an "off-the-shelf" ATMP and also being used in a clinical trial for the treatment of steroid-resistant Graft versus Host Disease. Secondly, defect derived autologous chondrons that are reinserted into the defect in combination with MSCs within one procedure. During surgery, the autologous defect derived chondrons will be combined with allogeneic cryopreserved and thawed MSCs to enhance cartilage formation. Cells will be combined at a ratio of 10% chondrons and 90% MSCs and mixed in Tisseel® which will act as a cell carrier scaffold. In the phase I-II trial we showed no significant differences in clinical outcome between these dosages. Tisseel® is a registered widely used two-component adhesive containing fibrinogen and thrombin concentrate. When mixed, these components mimic the final steps of blood coagulation and form a stable physiological fibrin clot. The ATMP will be applied to the cartilage defect in a concentration of approximately 2 million cells per ml of fibrin glue, 0,5 to 0,7 ml per cm\^2 will be administered. The amount of MSCs and chondrons is thus dependant of the size of the lesion. The cells will be applied in a ratio of 10:90 autologous chondrons: allogeneic MSCs.
To evaluate the clinical status/ improvement of the participants treated with the IMPACT therapy, the included participants will be asked to complete the Knee injury and Osteoarthritis Outcome Scoring (KOOS) and the EuroQoL 5-Dimension Health Questionnaire (EQ5D) at baseline (before IMPACT therapy) and at 3, 6, 9, 12 and 18 months follow-up.
To evaluate work leave and medical consumption a modified version iMTA Productivity cost questionnaire and iMTA Medical Consumption Questionnaire will be used.
A cost-effectiveness analysis will be performed to evaluate the extent to which IMPACT therapy affects costs compared to current treatment techniques. The costs of the procedures that are performed (i.e. IMPACT or current practice), as well as the costs of the product that is used (materials, operation theatre etc.), and the duration of the accompanying hospitalization episode, will be determined using the UMC Utrecht administrative data and study budget. In addition, the results of the iMTA Medical Consumption Questionnaire and the iMTA Productivity cost questionnaire will be used to collect data on respectively resource use and productivity loss during the rehabilitation period. All resource use will be multiplied with cost prizes, which will be obtained from the Dutch Healthcare Authority or from the Dutch manual for performing health economic evaluations, to calculate total societal costs. These costs will be combined with the QoL outcome measures (as described previously), to obtain an estimate of the cost-effectiveness of IMPACT as compared to current practice.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →This is the only study on the registry with R.J.H. Custers as lead sponsor.
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Inclusion Criteria:
Participants must meet the following criteria to be eligible for the study:
Inclusion criteria during surgery
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application of a mixture of allogenic MSC's and autologous chondrons with a fibrin cell carrier (Tisseel®) during one surgical procedure.
Drug: Instant MSC Product accompanying Autologous Chondron Transplantation
Optional physical therapy or pain medication, according to participants' desire for 9 months.
Application of a mixture of allogenic MSC's and autologous chondrons with a fibrin cell carrier (Tisseel®) in the cartilage defect of the knee during one surgical procedure.
Clinical change on scale of 0-100
KOOS-questionnaire (Knee injury and Osteoarthritis Outcome Score, 100 indicating no symptoms and 0 indicating extreme symptoms)
Time frame: At baseline, 3, 6 and 9 months
Quality of life change on scale of 0-100
EQ-5d-questionnaire (The EQ-5D-5L has 5 dimensions, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.)
Time frame: At baseline, 3, 6 and 9 months
Structural change of the cartilage tissue
MRI-scan
Time frame: At baseline, 6 and 18 months
Change in healtcare use and costs
iMTA-questionnaire (Medical Consumption and Productivity Cost Questionnaire)
Time frame: At baseline, 3, 6, 9, 12 and 18 months
Plan to share: Yes
Ran from Jul 2019 to primary completion in Sep 2025, 73 months.
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