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New One-Shot knee cartilage repair shows promise in trial

NCT ID NCT04236739

Disease control Sponsor: R.J.H. Custers Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a new one-step treatment called IMPACT for knee cartilage damage. It combines the patient's own cartilage cells with donor stem cells, applied during a single surgery. 60 people aged 18-45 with moderate to severe cartilage lesions were randomly assigned to either IMPACT or standard care (physical therapy and pain medication). The study aimed to see if IMPACT improves knee symptoms and quality of life more than standard care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a mixture of donor stem cells and the patient's own cartilage cells, applied with a glue-like gel during surgery
What this could lead to
If successful, this could offer a simpler, one-time surgical treatment for knee cartilage damage, potentially delaying or preventing osteoarthritis.
What could go wrong
This is a small Phase 3 trial with only 60 people. The treatment requires surgery, and long-term benefits or risks are not yet fully known. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Jul 2019

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must meet the following criteria to be eligible for the study: * Provides written informed consent, is able to understand the content of the study, understands the requirements for follow-up visits and is willing to provide the required information at follow-up visits and in the questionnaires. * Symptomatic articular cartilage lesion of the knee (femoral condyles or trochlea). * Age \>18 and \<45 years old Inclusion criteria during surgery * Participants must meet the following secondary criteria to be eligible for the study: * Modified Outerbridge Grade III or IV isolated cartilage lesion of the knee. * A post-debridement size of the cartilage lesion \> 2cm2 and ≤ 8 cm2 * At least 50% of functional meniscus remaining. Meniscal repair or resection is allowed during the IMPACT surgery provided that the surgeon is able to confirm that at least 50% of functional meniscus remains. * Stable knee ligaments (i.e. anterior and posterior cruciate ligaments). Exclusion Criteria: * Malalignment of \>5 degrees * (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. * (History of) Total meniscectomy 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 participants with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.

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Conditions

The condition(s) this trial relates to.

articular cartilage disorder Tooth, Impacted

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cartilage damage

Contacts and locations

Locations

  • University Medical Center Utrecht

    Utrecht, Utrecht, 3584 CX, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.