BridgeMD
Clinical Trial to evaluate the efficacy and safety of cell therapy for dry eye disease in Graft-versus-Host Disease (GvHD) context.
EU CTIS ID: 2024-519772-10-00
What this study is testing
To assess the efficacy and safety of subconjunctival ASC injection in patients with cGVHD and ocular involvement (severe Dry eye disease), by assessing the clinically and statistically significant improvement in disease-specific signs and symptoms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients over 18 years of age who understand and sign the informed consent.
- Diagnosis of severe cGVHD according to NIH criteria (reviewed by Lee SJ. in 2017) with ocular involvement in the form of severe dry eye disease in both eyes of more than 3 months' duration and objectively defined as superficial punctate keratitis >2 on the Oxford scale (range, 0-5) and/or presence of epithelial defect and, in addition, subjectively as a serious symptomatology, > 33 points in the OSDI questionnaire (0-100).
- Patients must have been previously treated, for at least three months, with blood derivatives and/or insulin eye drops and topical cyclosporine or tacrolimus (unless any of them has not been tolerated and has had to be discontinued for this reason);
- Patients should be using ocular lubricants at least 4 times a day and still have the criteria for severe dry eye disease in point 2.
- Patients in treatment with low doses of maintenance topical corticosteroids should have been on a stable dose for at least one month prior to inclusion
- The doses and frequency of application of all topical medicines with which the patient initiates the trial should be able to remain unchanged for the duration of the trial, unless otherwise judged by the investigator at a particular time.
You likely can't join if
- Uncontrolled systemic disease or any disease that, in medical judgment, could put the patient at risk or the interpretation of the results.
- Uncontrolled systemic cGvHD
- Active eye infection.
- Eye surgery within the last 3 months.
- Initiation of topical therapies for dry eye disease indicated in the inclusion criteria after 3 months prior to inclusion.
- Initiation of topical corticosteroid use during the 4 weeks prior to inclusion.
See the full eligibility criteria
- Patients over 18 years of age who understand and sign the informed consent.
- Diagnosis of severe cGVHD according to NIH criteria (reviewed by Lee SJ. in 2017) with ocular involvement in the form of severe dry eye disease in both eyes of more than 3 months' duration and objectively defined as superficial punctate keratitis >2 on the Oxford scale (range, 0-5) and/or presence of epithelial defect and, in addition, subjectively as a serious symptomatology, > 33 points in the OSDI questionnaire (0-100).
- Patients must have been previously treated, for at least three months, with blood derivatives and/or insulin eye drops and topical cyclosporine or tacrolimus (unless any of them has not been tolerated and has had to be discontinued for this reason);
- Patients should be using ocular lubricants at least 4 times a day and still have the criteria for severe dry eye disease in point 2.
- Patients in treatment with low doses of maintenance topical corticosteroids should have been on a stable dose for at least one month prior to inclusion
- The doses and frequency of application of all topical medicines with which the patient initiates the trial should be able to remain unchanged for the duration of the trial, unless otherwise judged by the investigator at a particular time.
- Systemic treatment of chronic GVHD should be stable in terms of the use of systemic immunosuppressants at least in the last month before patient inclusion or before treatment application.
- Negative urine pregnancy test result at baseline for women of childbearing potential. Subjects should be instructed to use contraception during their participation in the clinical trial and to take a new pregnancy test at the treatment visit if more than 28 days have passed since the baseline visit.
- Uncontrolled systemic disease or any disease that, in medical judgment, could put the patient at risk or the interpretation of the results.
- Uncontrolled systemic cGvHD
- Active eye infection.
- Eye surgery within the last 3 months.
- Initiation of topical therapies for dry eye disease indicated in the inclusion criteria after 3 months prior to inclusion.
- Initiation of topical corticosteroid use during the 4 weeks prior to inclusion.
- Cognitive alterations that may interfere with the fulfillment of the study.
- Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.