Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's D… (NCT02646007) | Clinical Trial Compass
UnknownPhase 1
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
Iran30 participantsStarted 2015-11
Plain-language summary
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Who can participate
Age range
18 Years – 65 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:
* Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
* Both genders
* Visual Analogue Scale of 4 or higher
* Hematological and biochemical analysis with no significant alterations that contraindicates intervention
* The patient is able to understand the nature of the study
* Informed written consent of the patient
Exclusion Criteria:
* Age over 65 or under 18 or legally dependent
* Infection signs or positive serology for HIV, hepatitis and syphilis
* Allergy to gentamicin, or to bovine, cattle or horse serum
* Pregnancy or lactating
* Pregnancy or breast-feeding
* Neoplasia
* Immunosuppression
* Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
* Other conditions that may, according to medical criteria, discourage participation in the study
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.