Stem cells from umbilical cord blood tested to repair knee cartilage
NCT ID NCT01733186
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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12 people
The number who actually took part.
- Started
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Jan 2013
- Finished
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Cartilage Repair Center; Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
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Cartilage Restoration Center; RUSH University Medical Center
Chicago, Illinois, 60612, United States
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