Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn (NCT03967275) | Clinical Trial Compass
CompletedNot Applicable
Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn
France7 participantsStarted 2020-09-09
Plain-language summary
The objective of this pre-clinical study is to demonstrate the robustness of Bone Marrow derived Mesenchymal Stem Cells (BM-MSC) production, to treat patients with severe eye burns.
For bone marrow donors who agree to participate, a 10 ml BM sample will be collected apart the 1 liter BM dedicated to transplantation.
A maximum of three donors of allogeneic BM-MSCs will be included. A ready-to-use BM-MSC suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.
Who can participate
Age range
18 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:
\- Patient with a bone marrow donation planned
Exclusion criteria:
* The donor is finally not eligible
* The harvest cannot be performed
* The sample cannot be obtained during the BM harvest procedure
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.
1This trial focused on finding enough bone marrow donors to support a stem cell treatment for severe chemical eye burns — since it has already been completed, would it be worth asking whether any results or published findings are available that could apply to my situation?
2The trial used allogeneic mesenchymal stem cells, meaning the cells come from a donor rather than the patient themselves — can you explain what that means for my immune system and whether there are known risks with receiving donor stem cells injected near my eye?
3Since this study is listed as 'Phase NA,' which suggests it may have been more of a feasibility or preparatory study rather than a full treatment trial, does that mean there is still limited safety and effectiveness data, and what would that mean if I were considering this as a treatment path?
4Are there currently any standard-of-care treatments for severe chemical eye burns that I should consider first before exploring experimental stem cell approaches like this one?
5Given that this trial was specifically about securing bone marrow donors and not directly testing outcomes in patients with chemical burns, is there a follow-on trial or related study that is actually testing this stem cell injection in patients that my care team thinks would be worth exploring?
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
The number of donors needed to obtain 3 BM harvest.
Timeframe: 6 months
Trial details
NCT IDNCT03967275
SponsorFondation Ophtalmologique Adolphe de Rothschild