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Doctoral Thesis
DOI
https://doi.org/10.11606/T.17.2020.tde-19092019-115150
Document
Author
Full name
Carina Costa Cotrim
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
Ribeirão Preto, 2019
Supervisor
Committee
Siqueira, Rubens Camargo (President)
Lira, Rodrigo Pessoa Cavalcanti
Pontes, Lorena Lôbo de Figueiredo
Jorge, Rodrigo
Title in Portuguese
Uso intravítreo de fração mononuclear da medula óssea (FMMO) contendo células CD34+ em pacientes portadores de Distrofia Macular tipo Stargardt
Keywords in Portuguese
Células hematopoiéticas
Células tronco
Distrofia de Stargardt
Abstract in Portuguese
Objetivos: Avaliar o potencial terapêutico e a segurança do uso intravítreo de fração mononuclear da medula óssea (FMMO) contendo células CD34+ em pacientes portadores de Distrofia Macular do tipo Stargardt (DMS). Casuística e Métodos: Foram avaliados 10 pacientes com Distrofia de Stargardt com acuidade visual no pior olho <=20/125. Foi obtido aspirado da medula óssea de todos os pacientes, e após o processamento do material no hemocentro, foi injetado 0,1 ml da suspensão de FMMO intravítreo no olho com pior acuidade. Foi realizada injeção simulada (Sham) no olho contralateral. Os pacientes foram avaliados no baseline, 1, 3, 6, 9 e 12 meses após a injeção. Todos realizaram medida da melhor acuidade visual corrigida (MAVC), microperimetria, eletrorretinografia multifocal (ERGmf) e de Campo Total, autofluorescência e Tomografia de coerência óptica (OCT). Também foi realizada angiografia fluoresceínica antes da injeção, seis e doze meses após. Resultados: Todos concluíram seis meses de avaliação e oito completaram nove meses e seis pacientes finalizaram os 12 meses. A média da acuidade visual antes da injeção intravítrea no olho tratado foi de 1,1 logMAR (20/250), em um e três meses após a injeção IV foi de 0,96 logMAR (20/200+2) e 0,92 logMAR (20/160-1), respectivamente; No olho não tratado, a média da AV no baseline foi de 1,0 logMAR ( 20/200) e com um e três meses foi de 0,96 logMAR (20/200+2), 0,94 logMAR (20/160-2), respectivamente. A AV no baseline no grupo T variou entre a melhor e pior acuidade, respectivamente, entre 20/125-1 a 20/640+2, passando para 20/100+2 e 20/400 no primeiro mês. No grupo NT, a acuidade visual variou no baseline de 20/100+2 a 20/400, 20/100 a 20/400 com um, Houve diferença estatisticamente significativa no grupo tratado em todos os seguimentos. No grupo não tratado, não houve diferença significativa. Em relação à média da sensibilidade da microperimetria, apesar da melhora em todos os meses, a diferença significativa ocorreu apenas no primeiro mês pela análise do teste T (p<0,01) e com doze meses na covariância (p<0,0097). No olho NT, não houve diferença significativa em nenhuma análise. A angiofluoresceinografia não apresentou crescimento de neovasos ou tumores. Os demais exames foram utilizados para auxílio diagnóstico. Conclusão: Os resultados indicam que o uso de FMMO intravítreo em pacientes com Distrofia de Stargardt é seguro e está associado à melhora da acuidade visual e microperimetria no olho tratado em comparação ao olho não tratado.
Title in English
Intravitreal use of bone marrow mononuclear fraction containing CD34+ stem cells in patients with Stargardt Macular Dystrophy
Keywords in English
Hematopoietic cells
Stargardt's dystrophy
Stem cells
Abstract in English
Objectives: To assess the therapeutic potential and the safety of the intravitreous use of a bone marrow mononuclear fraction (BMMF) containing CD34+ cells for patients with Stargardt's type Macular Dystrophy. Casuistic and Methods: The study was conducted on 10 patients with Stargardt's Dystrophy with worse eye visual acuity of <=20/125. A bone marrow aspirate was obtained from all patients and, after the material was processed at the blood center, 0.1 ml of intravitreous BMMF was injected into the eye with worse acuity. A sham injection was performed in the contralateral eye. The patients were evaluated at baseline and 1, 3, 6, 9 and 12 months after the injection. All patients were submitted to measurement of best corrected visual acuity (BCVA), microperimetry, multifocal and Full-Field electroretinography (ERGmf), autofluorescence, and Optical Coherence Tomography (OCT). Angiography was also performed before and six and 12 months after the injection. Results: All patients concluded six months of evaluation, eight completed nine months, and six finalized 12 months of study. Mean visual acuity was 1.1 logMAR (20/250) before intravitreous injection in the treated eye and 0.96 logMAR (20/200+2) and 0.96 logMAR (20/200+2), respectively, one and three months after IV injection. In the untreated eye, mean VA was 1.0 IogMAR (20/200) at baseline and 0.96 logMAR (20/200+2) and 0.94 logMAR (20/160-2) after one and three months, respectively. At baseline, the VA of the T group varied between the best and the worst acuity, 20/125-1 to 20/640+2, respectively, changing to 20/100+2 and 20/400 after the first month. In the untreated group, VA varied from 20/100+2 to 20/400. at baseline and from. 20/100 to 20/400 after one month. There was a statistically significant difference for the treated group at all follow-up times, whereas no significant difference was obseved in the untreated group. Regarding the mean sensitivity of microperimetry, despite improvement throughout the months, a significnant difference occurred only during the first month as determined by the T-test (p<0.01) and at 12 months using covariance (p<0.0097). No significant deference was detected in the untreated eye at any time point. Angiofluoresceinography did not reveal neovessel or tumor growth. The remaining exams were used for diagnostic help. Conclusions: The results indicate that the use of intravitreous BMMF in patients with Stargardt's dystrophy is safe and is associated with improved VA and microperimetry in the treated eye compared to the untreated one.
 
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CARINACOSTACOTRIM.pdf (3.84 Mbytes)
Publishing Date
2020-01-14
 
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