Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Valladolid | OTHER |
| Centro en Red de Medicina Regenerativa de Castilla y Leon | OTHER |
| Red de Terapia Celular | INDUSTRY |
The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Marrow mesenchymal stem cell | Experimental | Allogenic Bone Marrow mesenchymal stem cell in amniotic membrane transplant |
|
| Allogenic limbal stem cell Transplant | Active Comparator | Stem Cell with Amniotic Membrane Transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell with Amniotic Membrane Transplant | Procedure | Single stem cell expansion in amniotic membrane transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Viability and safety of mesenchymal stem cell transplant | Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of complications in pre and peri surgical implantation | Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification. | 1 Week |
| Improvement of 2 lines in Best Corrected Visual Acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margarita Calonge, MD, PhD | Instituto Universitario de OftalmobiologÃa Aplicada (Institute of Applied Ophthalmobiology) - IOBA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IOBA | Valladolid | Valladolid | 47011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37773479 | Derived | Perez I, Galindo S, Lopez-Miguel A, Nieto-Miguel T, de la Mata A, Lopez-Paniagua M, Alberca M, Herreras JM, Calonge M. In Vivo Confocal Microscopy in Limbal Stem Cell Deficiency After Mesenchymal Stem Cell Transplantation: A Sub-analysis from a Phase I-II Clinical Trial. Ophthalmol Ther. 2023 Dec;12(6):3251-3262. doi: 10.1007/s40123-023-00809-7. Epub 2023 Sep 29. | |
| 30578758 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Improvement in visual acuity compared to baseline values before transplant
| 12 month |
| Calonge M, Perez I, Galindo S, Nieto-Miguel T, Lopez-Paniagua M, Fernandez I, Alberca M, Garcia-Sancho J, Sanchez A, Herreras JM. A proof-of-concept clinical trial using mesenchymal stem cells for the treatment of corneal epithelial stem cell deficiency. Transl Res. 2019 Apr;206:18-40. doi: 10.1016/j.trsl.2018.11.003. Epub 2018 Nov 22. |