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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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A phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson's syndrome and mucous membrane pemphigoid with ocular involvement
A multicentre, nationwide clinical trial will be performed. 20 patients fulfilling eligibility criteria will be included in two different dose level cohorts: the first 10 patients included will receive a single cell application and the remainder 10 will be administered 2 cell applications separated by 15 days.
The investigational drug consists of locally administered, expanded, allogeneic adipose-derived adult mesenchymal stem cells (ASCs), at a dose of 5 million cells per ml (0,5 ml to be infused per quadrant)
Study cronogram: recruitment is estimated to take 8 months, and follow-up period will be 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells |
|
| Double dose Allogenic Adiposse derived mesenchimal stem cells | Experimental | Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Dose | Drug | Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of complications | Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period. | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Signs improvement | Changes from baseline in scarring conjunctivitis rating scale | At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks |
| Symptom improvement | Changes from baseline in Ocular Surface Disease Index (OSDI) questionnaire (0-48). The lower the rate obtained in the score, better the outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolás Alejandre Alba | Hospital Fundación Jiménez Diaz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Cruces | Barakaldo | Bizkaia | 48903 | Spain | ||
| Hospital General La Mancha Centro |
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2 consecutive cohorts will be included in order of recruitment. the first 10 patients will receive 1 single dose and the second 10 patients will receive 2 doses separated by 15 days
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| Double Dose | Drug | Repetead Dose: Administration of 2 doses, separated by 14 days, of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection. |
|
| At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks |
| Visual acuity improvement | Changes from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) (0-1,2). The higher the rate obtained in the score, better the outcome. | At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks |
| changes in quality of life | Changes from baseline using the specific National Eye Institute-Visual Function Questionnaire 25 (NEI-VFQ-25) (0-100). The value of 0 is the lowest and 100 the best possible | At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks |
| evolution of the conjunctival flora | variation in the number and type of microorganisms in the conjunctival exudates, performing cultures and PCR herpes viridae | At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks |
| Alcázar de San Juan |
| Ciudad Real |
| 13600 |
| Spain |
| Instituto Oftalmológico Fernández - Vega | Oviedo | Principality of Asturias | 33012 | Spain |
| Hospital La Arruzafa | Córdoba | 14012 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Fundación Jiménez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D010391 | Pemphigoid, Bullous |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D001327 | Autoimmune Diseases |
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