A Phase 1/2 interventional study of Cartilage repair surgery in Foreign-Body Reaction, Inflammation and Effusion (L) Knee, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by UMC Utrecht · Phase 1/2, Interventional, and Treatment
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
Compared within Inflammation, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: Single-stage, Cartilage repair, IMPACT
Safety: Adverse Events
Adverse events rate
Time frame: 18 months
Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score
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.
Time frame: 3 and 18 months
Structural Repair
To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.
Time frame: 12 months
Health Care Use and Costs
To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.
Time frame: 18 months
Patient recruitment started on February 1st 2013 and was completed in September 2014
| Milestone | Cartilage Repair Surgery |
|---|---|
| Started | 35 |
| Completed | 35 |
| Not completed | 0 |
Adverse events rate
| participants | Cartilage Repair Surgery |
|---|---|
| Safety: Adverse Events | 0 |
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.
| units on a scale | Cartilage Repair Surgery |
|---|---|
| KOOS outcome baseline | 57.9 ± 16.1 |
| KOOS outcome 3 months | 76.6 ± 11.1 |
| KOOS outcome 18 months | 85.4 ± 13.3 |
To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.
Results for this outcome have not been posted.
To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.
Results for this outcome have not been posted.
Collected over All patients were monitored for the duration of 18 months after surgery, at fixed time points (at 7 days, 6 weeks and 3,6,12 and 18 months after surgery), for inflammation and signs of a foreign body response by an independent physician (rheumatologist) using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and leukocyte count.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cartilage Repair Surgery | — | 0/35 (0%) | 18/35 (51.4%) |
| Event | Cartilage Repair Surgery |
|---|---|
| Post surgery (joint swelling, pain)Musculoskeletal and connective tissue disorders | 18/35 |
| Age, Categorical(Participants) | Cartilage Repair Surgery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 35 |
| >=65 years | 0 |
| Age, Continuous(years) | Cartilage Repair Surgery |
|---|---|
| Mean | 33 ± 8 |
| Sex: Female, Male(Participants) | Cartilage Repair Surgery |
|---|---|
| Female | 11 |
| Male | 24 |
| Region of Enrollment(participants) | Cartilage Repair Surgery |
|---|---|
| Netherlands | 35 |
The record gives a start of Mar 2013, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 2 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.