Stem cells and 3D printing join forces to mend broken bones and arthritic knees
NCT ID NCT07628010
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a combination of a patient's own stem cells and platelet-rich plasma to help heal broken bones that won't mend on their own and to treat knee arthritis. For people needing a knee replacement, doctors use custom 3D-printed guides made from the patient's scans to improve surgical precision. The goal is to see if these approaches are safe and can speed healing, reduce pain, and improve mobility.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Autologous mesenchymal stromal cells combined with platelet-rich plasma (MSC-PRP)
- What this could lead to
- If it works, this could offer a way to heal stubborn bone fractures and ease knee arthritis without major surgery, and make knee replacements more precise with faster recovery.
- What could go wrong
- This is an early-stage study with only 100 participants, so results may not apply to everyone. There is also a small risk of infection or reaction at the injection or surgical site.
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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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
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100 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: Male or female patients aged 18 to 80 years inclusive Diagnosis of one of the following orthopedic conditions: Delayed fracture healing or established non-union of a long bone fracture (at least 6 months after initial injury, confirmed radiographically) Symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2-4) Indication for primary unilateral total knee arthroplasty due to osteoarthritis Willing and able to provide written informed consent Able to comply with the study protocol, follow-up visits, and required examinations Exclusion Criteria: Active infection at the injection or surgical site, systemic infection, or history of recurrent infections Known malignancy or history of malignancy within the past 5 years (except basal cell carcinoma) Autoimmune or inflammatory rheumatic disease requiring systemic immunosuppressive therapy Uncontrolled diabetes mellitus (HbA1c \> 9.0%) Severe cardiovascular, renal, hepatic, or pulmonary disease that, in the investigator's opinion, makes the patient unsuitable for participation Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period Previous knee surgery (except diagnostic arthroscopy) in the target knee (for osteoarthritis and TKA groups) Contraindications to bone marrow aspiration or blood draw for PRP preparation Participation in another clinical trial within 30 days prior to screening Any medical condition that, in the investigator's judgment, would interfere with the assessment of safety or efficacy
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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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Zaporizhzhia State Medical and Pharamaceutical University
Zaporizhzhya, Ukraine
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a common bleeding drug make knee realignment surgery safer?