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Stem cells may boost ACL graft healing in new trial

NCT ID NCT04650568

Disease control Sponsor: Rush University Medical Center 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a patient's own bone marrow stem cells during ACL reconstruction helps the graft heal better. One hundred adults with recent ACL tears will receive either stem cells or a sham procedure. The main goal is to see if the graft looks healthier on MRI and if patients have better knee function and fewer symptoms.

What this could mean

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

Active substance
autologous bone marrow derived mesenchymal stem cells
What this could lead to
If it works, this could lead to faster and more complete healing of ACL grafts, reducing the need for repeat surgeries.
What could go wrong
This is an early-stage study with no phase, so results are uncertain. The stem cells come from the patient's own bone marrow, which requires an extra procedure and may not improve outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

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 60 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: * English-speaking patients * 18-60 years of age with acute ACL injury (\<6 months from time of injury to reconstruction) and undergoing reconstruction with patellar tendon allograft * Written informed consent is obtained Exclusion Criteria: * Revision Surgery * Prior history of knee surgery * Concomitant ligamentous injury * Inability to obtain an MRI * Inability to participate in follow-up for the study * Any patient lacking decisional capability * Diagnosed musculoskeletal cancer or any diagnosed cancer, other than * musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma * Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection or use of systemic steroids) * Known history of HIV, or has active Hepatitis B or active Hepatitis C * Alcohol and drug (medication) abuse * Pregnant or breast feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation. * Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the target knee in the 12 months prior to the injection procedure * Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study * Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

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

Anterior cruciate ligament injury Anterior cruciate ligament rupture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rush University Medical Center

    Chicago, Illinois, 60521, United States

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