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Stem cells from umbilical cord blood tested to repair knee cartilage

NCT ID NCT01733186

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tested a stem cell product called CARTISTEM in 12 adults with knee cartilage defects. The stem cells, derived from human umbilical cord blood, were implanted into the knee to see if they could safely help repair damaged cartilage. The study measured knee function and pain over 12 to 24 months, aiming to find a less invasive alternative to traditional surgery.

What this could mean

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

Active substance
human umbilical cord blood-derived mesenchymal stem cells (CARTISTEM)
What this could lead to
If successful, this could lead to a treatment that repairs knee cartilage without major surgery, potentially delaying or avoiding knee replacement.
What could go wrong
This is a very early, small trial (12 people) focused on safety. It may not work in larger groups, and long-term benefits or risks are unknown.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Jan 2013

Finished

Aug 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Patients with an intended- to- treat single focal, full-thickness cartilage defect (ICRS \[International Cartilage Repair Society\] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases. * Age ≥ 18 years old * Size of the articular cartilage lesion is ≥ 2 cm2 * Swelling, tenderness and active range of motion ≤ Grade II * Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening * Appropriate blood coagulation, kidney and liver function laboratory parameters: PT(INR) \< 1.5, APTT \<1.5×control Creatinine ≤ 2.0 mg/dL Albumin ≤ trace in urine dipstick test Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L * Ligament instability ≤ Grade II * Lower extremity alignment within 5 degrees of the neutral weight bearing axis * No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining * Ability and willingness to fully participate in the post-operative rehabilitation program * Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures * Body Mass Index (BMI) ≤ 35 kg/m2 Exclusion Criteria: * Patients who have been treated previously and are asymptomatic * Avascular necrosis/ osteonecrosis * Autoimmune or inflammatory joint disease * History of infection within the past 6 weeks * Surgery or radiation therapy within the past 6 weeks * Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator * Currently pregnant or nursing * Psychotic diseases, epilepsy, or any history of such diseases * Current abuse of alcohol (\> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker * Chronic inflammatory articular diseases such as rheumatoid arthritis * Enrolled in any other clinical trials within the past 4 weeks * Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks * Ligament instability \> Grade II * Uncorrected significant lower extremity malalignment (i.e. \> 5 degrees) * (sub-) Total meniscectomy (\<5mm rim remaining) * Corticosteroid or viscosupplementation injection to the affected knee in the past 3 months * Principal investigator considers inappropriate for the clinical trial due to any reasons other than those listed above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cartilage Repair Center; Brigham and Women's Hospital

    Chestnut Hill, Massachusetts, 02467, United States

  • Cartilage Restoration Center; RUSH University Medical Center

    Chicago, Illinois, 60612, United States

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