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Umbilical cord stem cells could mend Worn-Out knees

NCT ID NCT06981741

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether stem cells from donated umbilical cord tissue can safely help repair damaged knee cartilage. Fifty-five adults with moderate to severe cartilage defects will receive the cells placed on a collagen patch during surgery. Researchers will track serious side effects for two years and use MRI scans to measure cartilage regrowth.

What this could mean

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

Active substance
umbilical cord tissue stem cells (UC-MSC) placed on a collagen patch
What this could lead to
If it works, this could offer a new way to repair knee cartilage and reduce pain, potentially delaying or avoiding knee replacement.
What could go wrong
This is an early-phase trial with only 55 people, so results may not apply widely. Risks include surgery-related complications and the possibility that the stem cells do not improve cartilage healing.

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

About 55 people

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

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

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 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 of any gender with an age from ≥ 18 years to ≤ 60 years * Clinical indication for a surgical cartilage regeneration procedure * Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm * A cartilage defect requiring treatment with a defect size of 2-6 cm² on the femoral condyles or patella or trochlea * Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity \< grade III * KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and \> 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours * BMI \< 35 kg/m² * Written informed consent of the participant, also regarding alternative procedures such as cartilage transplantation (MACT) or matrix-augmented bone marrow stimulation (BMS, AMIC) Exclusion Criteria: * Clinical indication explicitly for a cartilage regeneration procedure other than the intended study treatment * Known varus or valgus malalignment of the affected leg of ≥ 5° * Antero-posterior or medio-lateral instability * Meniscus loss of more than 20% in the affected compartment * Patella instability * Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection \> 20%, osteotomy) * Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage ("kissing lesions") * Osteoarthritis Kellgren-Lawrence (K/L) grade III or IV * Arthrofibrosis * Metabolic arthropathy * Collagenosis * Autoimmune disease * Tumor disease within the last 5 years * Neuromuscular disease * Peripheral arterial occlusive disease * Intra-articular application of hyaluronic acid or glucocorticoids or platelet concentrates within the last 6 months * Joint replacement in the contra-lateral knee or hip within the last 12 months * Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout * Previous fracture in the affected knee joint * Osteoporosis * Contraindications against the planned operation under general anesthesia * Relevant secondary diseases that increase the risk of surgery, e.g. cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc. * History of known hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery * Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks prior to inclusion) * Addiction or other illnesses that do not allow the person concerned to assess the nature, scope and possible consequences of the clinical trial (lack of capacity to consent) * Indications that the patient is unlikely to adhere to the protocol (e.g. lack of compliance) * Persons who are placed in an institution by court or official order * Persons who are dependent on the sponsor * Pregnant or breastfeeding women * Women of childbearing age, except women who meet the following criteria: 1. Post-menopausal (12 months natural amenorrhea) 2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy) 3. Presence of a negative pregnancy test (urine, not older than 14 days on the day of surgery) and willingness to regularly and correctly use a contraceptive method with a Pearl Index \< 1 % per year: 3.1 Combined (oestrogen and progestogen-containing) hormonal contraception 3.2 Hormonal contraception containing progestogens (oral, injected, implanted) 3.3 IUD (hormonal IUD, copper IUD) 4. Sexual abstinence 5. Vasectomy of the partner

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Evangelisches Waldkrankenhaus Spandau

    RECRUITING

    Berlin, 13589, Germany

  • GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken

    RECRUITING

    Dinslaken, 46535, Germany

  • Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie

    RECRUITING

    Altenburg, 04600, Germany

  • Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie

    RECRUITING

    Greven, 48268, Germany

  • Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie

    RECRUITING

    Bamberg, 96049, Germany

  • St. Nikolaus Stifts-Hospital

    RECRUITING

    Andernach, 56626, Germany

  • UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden

    RECRUITING

    Dresden, 01307, Germany

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