Clinical Efficacy of Exosome in Degenerative Meniscal Injury (NCT05261360) | Clinical Trial Compass
UnknownPhase 2
Clinical Efficacy of Exosome in Degenerative Meniscal Injury
Turkey (Türkiye)30 participantsStarted 2022-03
Plain-language summary
Comparison of intra-articular administration of synovial fluid-derived mesenchymal stem cells-derived exosomes with synovial fluid-derived mesenchymal stem cells on the same patient.
Who can participate
Age range
30 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Accepting the Informed Consent Form
* Degenerative meniscus damage grade 1, 2 or 3 on MRI in both right and left knees, and also the patient does not want surgical treatment
* Patients with the same degenerative meniscus grade in both knees
* Patients with ongoing pain
* Patients without a history of malignancy
* Absence of signs of unstable meniscus tear such as snagging or locking
* Patients with stage 0, 1 or 2 gonarthrosis according to Kellgren-Lawrence gonarthrosis staging
* Patients without lower extremity malalignment
Exclusion Criteria:
* Patients whose treatment method was explained and who did not accept the method
* Patients outside the working-age range
* Congenital lesion
* Patients requiring surgical treatment (e.g. bucket handle tear and locked knee)
* Active inflammatory or connective tissue disease is thought to affect the patient's pain (eg lupus, rheumatoid arthritis, fibromyalgia)
* Local or systemic infection
* Pregnant or breastfeeding women
* Active endocrine disorder that may affect the assessment of patient's pain (eg, hypothyroidism, diabetes)
* Active neurological disorder that may affect the assessment of the patient's pain (eg, peripheral neuropathy, multiple sclerosis)
* Active heart disease
* Presence of a pacemaker
* Conditions where MR-I is contraindicated
* Patients with stage 3 or 4 gonarthrosis according to Kellgren-Lawrence gonarthrosis staging
* Patients with lower extremity malalignment
* Patients with signs of u…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of Knee Functions
Timeframe: Up to 12th months
2
Evaluation of Physical Activity
Timeframe: Up to 12th months
3
Evaluation of Pain
Timeframe: Up to 12th months
4
Evaluation of Radiological Images
Timeframe: Up to 12th months
5
Evaluation of Cytokine Levels and Cytokine Genes Analyzes