ES2310743T3 - Cola novedosa para la reconstruccion del cartilago. - Google Patents
Cola novedosa para la reconstruccion del cartilago. Download PDFInfo
- Publication number
- ES2310743T3 ES2310743T3 ES04749924T ES04749924T ES2310743T3 ES 2310743 T3 ES2310743 T3 ES 2310743T3 ES 04749924 T ES04749924 T ES 04749924T ES 04749924 T ES04749924 T ES 04749924T ES 2310743 T3 ES2310743 T3 ES 2310743T3
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- ES
- Spain
- Prior art keywords
- cartilage
- implant material
- defect according
- bone
- cartilage defect
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Abstract
Material de implante estéril de aloinjerto para defecto de cartílago destinado a ser usado en seres humanos, que comprende trozos de cartílago de aloinjerto molidos con un tamaño inferior a 1 mm liofilizados de manera que su contenido en agua oscila entre aproximadamente 0,1% y aproximadamente 8,0% en un portador bioabsorbible.
Description
Cola novedosa para la reconstrucción del
cartílago.
La presente invención se refiere en general a un
implante y más en concreto a un material de implante en forma de
pasta o gel para un defecto del cartílago.
El daño y deterioro del cartílago articular
presentan problemas médicos a la población normal que son tratados
por cirujanos ortopédicos. En Estados Unidos, cada año se realizan
500.000 operaciones de reparación de articulaciones. Estas incluyen
aproximadamente 125.000 artroplastias de cadera completa y 150.000
de rodilla completa y más de 41.000 operaciones artroscópicas
abiertas para reparar defectos de los cartílagos de la rodilla.
En la articulación de la rodilla, el tejido del
cartílago articular forma un revestimiento orientado hacia la
cavidad de la articulación por un lado y que por otro lado está
unido a la superficie ósea subcondral mediante una capa estrecha de
tejido de cartílago calcificado. El cartílago articular (cartílago
hialino) consiste principalmente en una matriz extracelular con una
escasa población de condrocitos distribuidos por todo el tejido. El
cartílago articular está formado por condrocitos, un retículo de
fibrillas colagenosas de tipo II, proteoglicanos y agua. Los
condrocitos activos son únicos ya que tienen una rapidez de
renovación relativamente baja y se distribuyen escasamente por los
alrededores de la matriz. Los colágenos proporcionan al tejido su
forma y resistencia a la tensión y la interacción entre los
proteoglicanos y el agua proporciona al tejido resistencia a la
compresión, elasticidad y durabilidad. El cartílago hialino
proporciona una superficie de contacto con poca fricción sobre las
partes óseas de la articulación. Si el revestimiento se desgasta o
daña produciendo lesiones, el movimiento de la articulación puede
producir dolor o verse sustancialmente restringido. Aunque el hueso
dañado puede normalmente regenerase de manera satisfactoria, la
regeneración del cartílago hialino es bastante limitada debido a la
limitación de sus capacidades regenerativas y reparativas.
Las lesiones de cartílago articular normalmente
no se curan o sólo se curan parcialmente en determinadas condiciones
biológicas debido a la falta de nervios, vasos sanguíneos y un
sistema linfático. La limitada capacidad reconstructiva del
cartílago hialino da normalmente como resultado la generación de
tejido reconstructivo carente de la estructura y de las propiedades
biomecánicas del cartílago normal. En líneas generales, la curación
del defecto tiene como resultado un tejido reconstructivo
fibrocartilaginoso que carece de la estructura y de las propiedades
biomecánicas del cartílago hialino y se degrada con el tiempo. Las
lesiones de cartílago articular están frecuentemente asociadas con
discapacidad y con síntomas tales como dolor de las articulaciones,
fenómenos de bloqueo y funcionamiento reducido o alterado. Es
difícil tratar las lesiones debido a la estructura y función
peculiares del cartílago hialino. Se cree que tales lesiones
degeneran en formas de osteoartritis. La osteoartritis es la causa
principal de discapacidad y deterioro en individuos de mediana edad
y más mayores, lo que implica costes económicos, sociales y
psicológicos significativos. Cada año, la osteoartritis supone hasta
39 millones de visitas médicas y más de 500.000 hospitalizaciones.
Para el año 2020 se espera que afecte a casi 60 millones de personas
en los Estados Unidos y que limite la actividad de 11,6 millones de
personas.
Actualmente se usan muchos métodos terapéuticos.
Ninguna de estas terapias ha hecho que se regenere de manera
satisfactoria el tejido de tipo hialino que soporta la carga y
actividad normales de las articulaciones durante periodos
prolongados. Actualmente, las técnicas más utilizadas clínicamente
para defectos y deterioros del cartílago no son procesos en los que
se reemplaza el cartílago articular, sino procesos de limpieza,
desbridamiento artroscópico y estimulación de la reparación. El
transplante directo de células o tejido en un defecto y el
reemplazo del defecto por sustitutos biológicos o sintéticos suponen
actualmente sólo un pequeño porcentaje de las intervenciones
quirúrgicas. El objetivo quirúrgico óptimo consiste en reemplazar el
defecto por sustitutos de tipo cartílago para aliviar el dolor,
reducir derrames e inflamaciones, funciones de restauración, reducir
la discapacidad y posponer la necesidad de colocar prótesis.
La limpieza y el desbridamiento artroscópico
implican tener que irrigar la articulación con soluciones de
cloruro de sodio, Ringer o Ringer y lactato. Se cree que el alivio
temporal del dolor se debe a la retirada de residuos de cartílago
degenerativo, encimas proteolíticas y mediadores inflamatorios.
Estas técnicas proporcionan un alivio temporal del dolor, pero
tienen pocas posibilidades o ninguna posibilidad de curación.
La estimulación de la reparación se realiza
mediante peforación, artroplastia de abrasión o microfractura. La
penetración en el hueso subcondral induce al sangrado y a la
formación de coágulos de fibrina que estimula la reparación
inicial, pero sin embargo el tejido formado es de naturaleza fibrosa
y no es duradero. El alivio del dolor es temporal ya que el tejido
muestra características de deterioro, de pérdida de elasticidad, de
resistencia y de desgaste con el tiempo.
Se ha demostrado que el periostio y el
pericondrio contienen células madre mesenquimales que pueden
diferenciarse y proliferar. Estas se han usado como injertos tanto
en modelos animales como humanos para reparar defectos de las
articulaciones. En pocos pacientes de más de 40 años se han obtenido
buenos resultados clínicos, lo que probablemente refleja el
descenso de la población de células madres osteocondrales con el
aumento de la edad. También ha habido problemas con la adhesión y
estabilidad de los injertos, lo que hace que se desplacen o se
salgan del lugar de reparación.
El trasplante de células que han crecido por
cultivo proporciona otro método para introducir una nueva población
de células en defectos condrales y osteocondrales. Carticel® es un
proceso comercial, comercializado por Genzyme Biosurgery en Estados
Unidos y Europa, para cultivar células del cartílago del propio
paciente a fin de usarlas en la reparación de los defectos de
cartílago en el cóndilo femoral. El procedimiento usa artroscopia
para hacer una biopsia de una zona sana y menos cargada del
cartílago articular. La digestión enzimática del tejido recogido
libera las células que son enviadas a un laboratorio donde crecen
durante un periodo comprendido entre 2 y 5 semanas. Una vez
cultivadas, las células se inyectan, durante un proceso de rodilla
más abierto y extensivo, en zonas del cartílago defectuoso donde se
espera que faciliten la reparación del tejido dañado. Un colgajo
perióstico autólogo con una capa interna o cambium se usa para
sellar las células trasplantadas in situ y actúa como
barrera mecánica. Se usa adhesivo a base de fibrina para sellar los
bordes del colgajo. Esta técnica protege la superficie ósea
subcondral y presenta un índice de éxitos alto. Los defensores de
este procedimiento declaran que produce resultados satisfactorios,
entre los que se incluye la posibilidad de volver a desempeñar
actividades físicas difíciles en más de un 90% de los pacientes y
que los especimenes de la biopsia del tejido en los lugares del
injerto muestran una reparación del cartílago de tipo hialino. Se
necesita más trabajo para valorar la función y duración del nuevo
tejido y determinar si mejora la función de la articulación y si
retrasa o previene el deterioro de las articulaciones. Al igual que
con el injerto periocondral, la edad del paciente/donante puede
afectar negativamente al éxito de este procedimiento ya que la
población de condrocitos disminuye con el aumento de la edad. Las
desventajas de este procedimiento incluyen la necesidad de dos
procedimientos quirúrgicos independientes, el posible daño del
cartílago circundante cuando se cose el parche perióstico en su
lugar, la demanda de técnicas microquirúrgicas difíciles y que los
altos costes del procedimiento no los cubre el seguro.
El trasplante osteocondral o mosaicoplastia
incluye extirpar todo el tejido inestable o dañado del defecto de
la articulación y crear agujeros cilíndricos en la base del defecto
y del hueso subyacente. Estos agujeros se rellenan con tapones
cilíndricos autólogos de cartílago y hueso sanos a modo de mosaico.
Los tapones osteocondrales se recogen de una zona de la misma
articulación menos importante y que soporta menos peso. Esta
técnica, que se muestra en el estado de la técnica de la figura 2,
se puede realizar como procedimientos artroscópicos o abiertos.
Informes de los resultados de osteochondral plug
autografts/autoplastias de tapón osteocondrales en un número
pequeño de pacientes indican que reducen el dolor y mejoran la
función de la articulación, pero sin embargo no se han presentado
los resultados a largo plazo. Entre los factores que pueden
perjudicar los resultados se incluyen morbibidad del lugar del
donante, efectos de incompatibilidad de la articulación en la
superficie opuesta del lugar del donante, daño a los condrocitos en
los márgenes articulares de los lugares del donante y del receptor
durante la preparación e implantación y colapso o decantación del
injerto con el tiempo. La limitada disponibilidad de los lugares
para recoger autoinjertos osteocondrales restringe el uso de este
acceso para tratar defectos de las articulaciones relativamente
pequeños y la curación entre la parte condral del autoinjerto y el
cartílago de la articulación adyacente sigue siendo de interés.
El trasplante de aloinjertos grandes de hueso y
de cartílago articular subyacente es otra opción de tratamiento que
necesita un área más grande que la conveniente para tapones
cilíndricos autólogos, y también para un defecto no incluido. Las
ventajas de los aloinjertos osteocondrales son su potencial para
restaurar el contorno anatómico de la articulación, la falta de
morbibidad asociada a la recogida de injertos, mayor disponibilidad
que los autoinjertos y la capacidad de preparar aloinjertos de
cualquier tamaño para reconstruir defectos grandes. La experiencia
clínica con aloinjertos osteocondrales frescos y congelados
demuestra que estos injertos pueden aliviar el dolor de las
articulaciones, y que la parte ósea de un aloinjerto puede curar
hasta el hueso huésped y la parte condral puede funcionar como una
superficie articular. Entre las desventajas asociadas con esta
metodología en la situación clínica se incluyen la escasez de
material fresco de donantes y los problemas asociados con la
manipulación y almacenaje de tejido congelado. Los aloinjertos
pueden incluir el riesgo de una respuesta inmune o la transmisión
de enfermedades. La Fundación de Trasplantes Musculoesqueléticos
(MTF) ha conservado aloinjertos frescos en un medio que mantiene
una viabilidad celular del 50% durante 35 días para usar como
implantes. Los aloinjertos congelados carecen de viabilidad celular
y muestran una cantidad reducida de contenido de proteoglicanos lo
que contribuye a deteriorar el tejido.
Varias patentes del estado de la técnica
muestran el uso de cera, pastas o geles de hueso para rellenar
defectos de huesos. La patente U.S. 5.290.558 cedida el 1 de marzo
de 1994, describe una composición en polvo de hueso desmineralizado
que usa un polvo de hueso osteogénico con un tamaño de partículas
grande comprendido entre aproximadamente 0,1 y aproximadamente 1,2
cm, mezclado con un compuesto polihidroxi de bajo peso molecular
que posee entre 2 y aproximadamente 18 carbonos incluidas varias
clases de compuestos diferentes tales como monosacáridos,
disacáridos, oligosacáridos dispersables en agua y
polisacáridos.
Un gel de hueso se describe en la patente U.S.
5.073.373 cedida el 17 de diciembre de 1991. Laminillas óseas en
forma de hilos o filamentos que contienen un portador de glicerol de
bajo peso molecular se muestran en las patentes U.S. 5.314.476
cedida el 24 de mayor de 1994 y la 5.507.813 cedida el 16 de abril
de 1996, y las formas de tejido descritas en estas patentes se
conocen comercialmente como Putty y Flex GRAFTON®,
respectivamente.
La patente U.S. 5.356.629 cedida el 18 de
octubre de 1994, describe hacer un gel rígido de naturaleza de
cemento de hueso para rellenar defectos de huesos mezclando
partículas biocompatibles, de preferencia polimetilmetacrilato
revestido con polihidroximetilmetacrilato en una matriz seleccionada
de un grupo que incluye ácido hialurónico para obtener una masa
semisólida moldeada que puede trabajarse de forma adecuada para
implantarla en un hueso. El ácido hialurónico también puede
utilizarse en forma monomérica o polimérica, de preferencia con un
peso molecular no superior a aproximadamente un millón de daltones.
Se puede apreciar que el material no bioabsorbible que puede usarse
para formar las partículas biocompatibles puede derivar de hueso
xenoinjerto, hueso homólogo, hueso autógeno y de otros materiales.
La sustancia bioactiva también puede ser un agente osteogénico tal
como polvo de hueso desmineralizado, hueso esponjoso morselizado,
médula ósea aspirada y otras fuentes óseas autógenas. El tamaño
medio de las partículas empleadas está comprendido entre
aproximadamente 0,1 y 3,0 mm, de preferencia entre aproximadamente
0,2 y 5,5 mm y más preferiblemente entre aproximadamente 0,3 y 1,0
mm. Se menciona por inducción aunque no se ha demostrado que se
pueden usar partículas con tamaños medios de entre aproximadamente
7.000 y 8.000 micrómetros, o incluso con un menor tamaño de entre
100 y 700 micrómetros.
La patente U.S. 4.172.128 cedida el 23 de
octubre de 1979 describe un material óseo desmineralizado mezclado
con un portador para reconstruir material dental u óseo añadiendo un
mucopolisacárido a un material coloidal óseo desmineralizado. La
composición se forma a partir de un material óseo molido en basto,
que puede derivar de huesos y dientes humanos, disuelto en un
disolvente que forma una solución coloidal a la que se añade un
compuesto polihidroxi fisiológicamente inerte tal como un
mucosacárido o un ácido poliurónico en una cantidad que produce
orientación cuando se añaden iones de hidrógeno o iones metálicos
polivalentes para formar un gel. El gel es fluido a temperaturas
elevadas por encima de 35ºC y se solidifica cuando las temperaturas
descienden a la temperatura corporal. El ejemplo 25 de la patente
indica que los mucopolisacáridos producen efectos inotrópicos
pronunciados y que el ácido hialurónico es en concreto responsable
de entrecruzamiento espacial.
La patente U.S. 6.030.635 cedida el 29 de
febrero de 2000 y la patente U.S. 6.437.018 cedida el 20 de agosto
de 2002, se refieren a una cera de hueso maleable y a una
composición de gel fluido para aplicarlas en el lugar donde se
encuentra un defecto de hueso a fin de estimular un nuevo
crecimiento óseo en el lugar que utiliza un compuesto que produce
un nuevo crecimiento óseo de polvo de hueso aloinjerto liofilizado
desmineralizado. El polvo de hueso tiene un tamaño de partículas
comprendido entre aproximadamente 100 y aproximadamente 850
micrómetros y se mezcla en un portador hidrogel de alto peso
molecular que contiene un tampón salino de fosfato de sodio.
El uso de implantes para defectos de cartílago
es mucho más limitado. Además de los implantes aloinjertos frescos
y de los implantes autólogos, la patente U.S. 6.110.209 cedida el 5
de noviembre de 1998 muestra el uso de una pasta de hueso esponjoso
de cartílago articular autólogo para rellenar defectos artríticos.
La técnica quirúrgica es artroscópica e incluye desbridar (recortar
cartílago articular fragmentado o suelto), y después morselizar la
base del defecto artrítico con una lenza hasta que comience el
sangrado. Después se recoge un injerto osteocondral del borde
interno del corte intercondilar usando un trépano. El injerto se
morseliza después en un triturador de injertos de hueso, mezclando
el cartílago articular con el hueso esponjoso. La pasta se
introduce después en el defecto y se asegura con las propiedades
adhesivas del hueso sangrante. La pasta también se puede mezclar
con un factor estimulador de cartílago, una pluralidad de células o
una cola biológica. Todos los pacientes se mantienen a dieta durante
cuatro semanas y se usa una máquina de movimiento pasivo continuo
durante seis horas cada noche. El aspecto histológico de las
biopsias muestran principalmente una mezcla de fibrocartílago con
cartílago hialino. Las preocupaciones asociadas a este método son
morbibidad y disponibilidad del lugar de recogida, similares a las
del método de mosaicoplastia.
Un material de implante de cartílago en forma de
pasta o gel para reparar defectos de cartílago articular está
formado por trozos de cartílago de aloinjerto molidos en un portador
bioabsorbible. También se puede aplicar a la matriz una cantidad de
condrocitos autólogos que sobrepase el número que se produce
naturalmente en un cartílago hialino para un adulto maduro de entre
20 y 55 años de edad. Se pueden aplicar aditivos a la mezcla para
aumentar la migración y proliferación de condrocitos. El material de
implante puede tolerar la adición de varios factores estimulantes
condrogénicos que incluyen, aunque no se limitan a, factores de
crecimiento (FGF-2, FGF-5,
IGF-1, TGF-\beta,
BMP-2, BMP-7, PDGF, VEGF),
condrocitos alogénicos o autólogos humanos, células alogénicas
humanas, células de la médula ósea alogénicas humanas, células de la
médula ósea autólogas humanas, células primitivas alogénicas
humanas, células primitivas autólogas humanas, una matriz ósea
desmineralizada, insulina, factor de crecimiento-1
de tipo insulina, antagonista del receptor de la
interleucina-1, factor de crecimiento del
hepatocito, factor de crecimiento derivado de las plaquetas,
hedgehog Indio y péptido relacionado con la hormona
paratifoidea.
El material de implante se coloca en la zona
lesionada y puede sellarse con un casquete perióstico.
Un propósito de la invención es proporcionar un
material de implante de aloinjerto para articulaciones que
proporcione una alivio del dolor, que recupere la función normal y
que posponga o elimine la necesidad de colocar prótesis.
Es también un propósito de la invención
proporcionar un material de implante para reparar cartílagos que
pueda colocar fácilmente el cirujano en la zona defectuosa usando
una técnica artroscópica mínimamente invasiva.
Es también otro propósito de la invención
proporcionar un material de implante de aloinjerto que pueda
aplicarse en lesiones tanto con un grosor parcial como total.
Otro propósito más de la invención es
proporcionar un material de implante de aloinjerto que facilite el
crecimiento de cartílago hialino.
Otro propósito de la invención consiste en
proporcionar fórmulas de material de de implante en forma de pasta
o gel que satisfagan las necesidades médicas y que se hagan a partir
de tejido de aloinjerto donado por humanos, parte del cual sería
considerado producto de desecho en otras circunstancias y
desechado.
Estos y otros propósitos, ventajas y
características novedosas de la presente invención quedan claros
cuando se consideran junto con las enseñanzas que se encuentran en
la descripción detallada y los dibujos en anexo.
La figura 1, muestra la anatomía de una
articulación de rodilla con una lesión.
La figura 2, muestra una mosaicoplastia
esquemática del estado de la técnica; y
La figura 3, muestra una vista en perspectiva
esquemática de material para defecto de cartílago colocado en el
lugar donde se encuentra un defecto con un casquete perióstico
separado.
Aquí, el término "tejido" se refiere en
general a cualquier tejido que se pueda trasplantar o implantar,
cuya capacidad de conservación se mejora al implantarlo con los
métodos que se describen. En concreto, la duración y longevidad
total del implante se mejoran, y se eliminan sustancialmente las
respuestas del sistema huésped-inmunológico.
Los términos "trasplante" e "implante"
se usan de manera intercambiable para referirnos al tejido, material
o células (xenogénicas o alogénicas) que pueden introducirse en el
cuerpo de un paciente para reemplazar o complementar la estructura o
función del tejido endógeno.
Los términos "autólogo" y
"autoplastia" se refieren a tejido o células que se originan en
o derivan del receptor, mientras que los términos "alogénico"
y "aloinjerto" se refieren a células y tejido que se originan
en o derivan de un donante de la misma especie que el receptor. Los
términos "xenogénico" y "xenoinjerto" se refieren a
células o tejido que se origina en o derivan de una especie
diferente a la del receptor.
El término "gel" se refiere a una mezcla de
cartílago aloinjerto picado o molido pretratado en un portador con
una viscosidad inferior y menos rígida que una mezcla de cartílago
aloinjerto picado o molido pretratado en un portador biocompatible
denominado "cera" o "pasta" y contiene menos cartílago en
peso que la cera o la pasta.
La presente invención se refiere a un material
para reconstruir cartílago y a un método de tratamiento. La
realización preferida y el mejor modo de llevar a cabo la invención
se muestran en la figura 3. En la invención, se liofiliza cartílago
hialino aloinjerto reduciendo su contenido de agua y se muele para
facilitar su aplicación.
Después de limpiar varias veces el material para
reconstruir cartílago con agua desionizada (DI), se congela a
temperaturas de entre -20º y -100ºC, de preferencia a -70ºC y se
liofiliza para reducir el contenido de agua a una proporción de
entre aproximadamente 0,1% y aproximadamente 8,0%. El cartílago se
congela con nitrógeno líquido y se muele en partículas.
Una lesión o defecto se elimina abriendo un
agujero 50 en la zona de implante 100 ó extirpando una lesión de la
misma zona de implante 100 y rellenando el agujero 50 o zona
lesionada con una mezcla de cartílago molido 20 de pasta o gel que
consta de un portador biológico tal como ácido hialurónico y sus
derivados, gelatina, colágeno, quitosana, alginato, un tampón de
PBS, dextrano o polímeros y uno o más aditivos, a saber factores
estimulantes condrogénicos que incluyen, aunque no se limitan a,
factores de crecimiento (FGF-2,
FGF-5, IGF-1,
TGF-\beta, BMP-2,
BMP-7, PDGF, VEGF), condrocitos alogénicos o
autólogos humanos, células alogénicas humanas, células de la médula
ósea alogénicas humanas, células de la médula ósea autólogas
humanas, células primitivas alogénicas humanas, células primitivas
autólogas humanas, una matriz ósea desmineralizada, insulina, factor
de crecimiento-1 de tipo insulina, antagonista del
receptor de la interleucina-1, factor de crecimiento
del hepatocito, factor de crecimiento derivado de las plaquetas,
hedgehog Indio y péptido relacionado con la hormona
paratifoidea.
Se puede utilizar un material de cola orgánica
adecuado para mantener la mezcla de cartílago viscosa 20 in situ en
la zona de implante o para fijar un casquete perióstico 30 in
situ sobre la zona de cartílago hialino circundante 100. Se
puede encontrar comercialmente material de cola orgánica adecuado
tal como por ejemplo TISSEEL® o TISSUCOL® (adhesivo a base de
fibrina; Immuno AG, Austria). Proteína adhesiva (Sigma Chemical,
USA), y Dow Corning Medical Adhesive B (Dow Corning, USA).
Una matriz de cera de cartílago picado que
consta de cartílago articular aloinjerto molido que se ha
liofilizado, de modo que su contenido en agua oscila entre 0,1% y
8,0%, con un contenido de cartílago comprendido entre 25% y 50% en
peso, se mezcla con un portador de una solución de hialuronato de
sodio (HA) ( peso molecular entre 7,0 x 10^{5} y 1,2 x 10^{6})
o con cualquier otro portador bioabsorbible tal como un ácido
hialurónico y sus derivados, gelatina, colágeno, quitosana,
alginato, un tampón de PBS, dextrano o polímeros estando el
portador comprendido entre 75% y 50% en peso. El cartílago se muele
hasta un tamaño comprendido entre 0,01 y 1 mm. En forma de gel, el
cartílago picado que se ha liofilizado para que su contenido de
agua esté comprendido entre 0,1% y 8,0%, oscila entre 15% y 30% en
peso y el portador está comprendido entre 85% y 70% en peso. El
tamaño de partícula del cartílago cuando está molido es menor o
igual a 1 mm en seco en la escala mencionada. Los trozos de
cartílago se pueden procesar para variar el tamaño de partícula y
el HA u otro portador pueden tener diferentes viscosidades
dependiendo de la consistencia deseada de la cera o la pasta. La
matriz de cartílago puede depositarse artroscópicamente en el
defecto del cartílago y fijarse en el defecto donde se mantiene
in situ gracias a su propia viscosidad, mezclada con adhesivo
a base de fibrina o recubierta con un colgajo perióstico o
pericondral, y después sellarse con adhesivo biológico. Igual que
con las dos primeras matrices, esta matriz puede incluir los
factores condrogénicos mencionados.
Una matriz de cera de cartílago picado que
consta de cartílago aloinjerto molido que se ha liofilizado con lo
cual su contenido en agua está comprendido entre 0,1% y 8,0%
oscilando entre 25% y 50% en peso se mezcla con un portador de una
solución de hialuronato de sodio (HA) (peso molecular entre 7,0 x
10^{5} y 1,2 x 10^{6}) o con cualquier otro portador
bioabsorbible tal como un ácido hialurónico y sus derivados,
gelatina, colágeno, quitosana, alginato, un tampón de PBS, dextrano
o polímeros estando el portador comprendido entre 75% y 50% en
peso. El cartílago se muele hasta un tamaño comprendido entre 0,01 y
1 mm. En forma de gel, el cartílago picado que se ha liofilizado
para que su contenido de agua que está comprendido entre 0,01% y
8,0% oscila entre 15% y 30% en peso y el portador está comprendido
entre 85% y 70% en peso. El tamaño de partícula del cartílago es
menor o igual a 1 mm en seco oscilando entre 0,01 y 1 mm. Los trozos
de cartílago se pueden procesar para variar el tamaño de partícula
y el HA u otro portador pueden tener diferentes viscosidades
dependiendo de la consistencia deseada de la cera o la pasta. Las
células autólogas o alogénicas que han crecido fuera del paciente
se insertan con una jeringa en la matriz antes, durante o después de
depositar la matriz del cartílago en la zona defectuosa. Tales
células incluyen células de la médula ósea alogénicas, células de la
médula ósea autólogas, células primitivas y células cartilaginosas.
La densidad celular de las células está comprendida preferiblemente
entre aproximadamente 1 x 10^{8} y 5 x 10^{8} ó entre
aproximadamente 100 millones y aproximadamente 500 millones de
células por cc de mezcla de cera o gel. Este material compuesto
puede inyectarse artroscópicamente en el defecto del cartílago y
fijarse en el defecto donde se mantiene in situ gracias a su propia
viscosidad, o recubrirse con un colgajo perióstico o pericondral, y
después sellarlo con adhesivo biológico. Como con la primera
matriz, esta matriz puede incluir los factores condrogénicos
mencionados.
La operación que consiste en colocar la
composición de cartílago en un defecto de cartílago, comprende: (a)
cortar el tejido de un paciente por el lugar donde se encuentra el
defecto del cartílago a fin de eliminar la zona dañada del
cartílago; (b) colocar una mezcla de cartílago aloinjerto molido en
un portador bioabsorbible en la zona defectuosa; y (c) colocar una
cubierta perióstica sobre la mezcla del cartílago aloinjerto molido
en un portador bioabsorbible para acomodar la mezcla en la zona
defectuosa durante un periodo de tiempo determinado a fin de
estimular el crecimiento de cartílago por el sitio defectuoso. Otros
pasos incluyen la adición de factores de crecimiento, condrocitos,
células de la médula ósea y células primitivas.
Claims (11)
1. Material de implante estéril de aloinjerto
para defecto de cartílago destinado a ser usado en seres humanos,
que comprende trozos de cartílago de aloinjerto molidos con un
tamaño inferior a 1 mm liofilizados de manera que su contenido en
agua oscila entre aproximadamente 0,1% y aproximadamente 8,0% en un
portador bioabsorbible.
2. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
cartílago molido oscila entre aproximadamente 25% y aproximadamente
50% en peso y dicho portador oscila entre aproximadamente 75% y
aproximadamente 50% en peso.
3. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
cartílago molido oscila entre aproximadamente 15% y aproximadamente
30% en peso y dicho portador oscila entre aproximadamente 85% y
aproximadamente 70% en peso.
4. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
portador es hialuronato de sodio y sus derivados.
5. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
material de implante incluye una cola proteica.
6. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
material de implante incluye la adición de condrocitos autólogos
para obtener una concentración que sobrepase la concentración de
condrocitos que se presentan naturalmente en el paciente.
7. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
cartílago molido se toma de un grupo formado por uno o más
cartílagos de un cartílago hialino y de un cartílago fibroso.
8. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, que incluye un
aditivo en dicho material de implante formado por uno o más
elementos de un grupo formado por los factores de crecimiento
tomados de un grupo formado por FGF-2,
FGF-1, IGF-1,
TGF-\beta, BMP-2,
BMP-7, PDGF, VEGF, células alogénicas humanas,
células de la médula ósea alogénicas humanas, células de la médula
ósea autólogas humanas, células primitivas alogénicas humanas,
células primitivas autólogas humanas, una matriz ósea
desmineralizada humana e insulina.
9. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dichos
trozos de cartílago articular de aloinjerto molidos tienen un
tamaño que oscila entre 0,01 mm y 1,0 mm y dicho portador
bioabsorbible se toma de un grupo formado por hialuronato de sodio,
ácido hialurónico y sus derivados, gelatina, colágeno, quitosana,
alginato, un tampón de PBS, dextrano o polímeros y condrocitos
alogénicos presentes en una cantidad que sobrepasa la ocurrencia
natural de los mismos en el cartílago articular.
10. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
material de implante tiene una cantidad de células de la médula ósea
que sobrepasa la ocurrencia natural de las mismas en un paciente en
tratamiento.
11. Material de implante estéril de aloinjerto
para defecto de cartílago según la reivindicación 1, en donde dicho
material de implante incluye la adición de una cantidad de
condrocitos alogénicos que sobrepasa la ocurrencia natural de los
mismos en un paciente en tratamiento.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/424,765 US7067123B2 (en) | 2003-04-29 | 2003-04-29 | Glue for cartilage repair |
| US424765 | 2003-04-29 | ||
| US56661804P | 2004-04-30 | 2004-04-30 | |
| US11/081,103 US20060210643A1 (en) | 2003-04-29 | 2005-03-16 | Cartilage repair mixture containing allograft chondrocytes |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2310743T3 true ES2310743T3 (es) | 2009-01-16 |
Family
ID=40786705
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES04749924T Expired - Lifetime ES2310743T3 (es) | 2003-04-29 | 2004-04-21 | Cola novedosa para la reconstruccion del cartilago. |
Country Status (8)
| Country | Link |
|---|---|
| US (7) | US7067123B2 (es) |
| EP (2) | EP1618178B1 (es) |
| AT (1) | ATE401090T1 (es) |
| AU (2) | AU2004235291B2 (es) |
| CA (2) | CA2522133C (es) |
| DE (1) | DE602004015093D1 (es) |
| ES (1) | ES2310743T3 (es) |
| WO (2) | WO2004096983A2 (es) |
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| WO2005110278A2 (en) | 2005-11-24 |
| ATE401090T1 (de) | 2008-08-15 |
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| CA2563082A1 (en) | 2005-11-24 |
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| AU2005244247A1 (en) | 2005-11-24 |
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| US20060210643A1 (en) | 2006-09-21 |
| US20080133008A1 (en) | 2008-06-05 |
| CA2522133C (en) | 2010-11-16 |
| CA2563082C (en) | 2012-07-10 |
| US7067123B2 (en) | 2006-06-27 |
| AU2004235291A1 (en) | 2004-11-11 |
| EP1618178A4 (en) | 2006-07-26 |
| WO2005110278A3 (en) | 2006-08-10 |
| DE602004015093D1 (de) | 2008-08-28 |
| US20140058527A1 (en) | 2014-02-27 |
| EP1618178B1 (en) | 2008-07-16 |
| EP1740121A2 (en) | 2007-01-10 |
| WO2004096983A2 (en) | 2004-11-11 |
| US20040219182A1 (en) | 2004-11-04 |
| USRE42208E1 (en) | 2011-03-08 |
| EP1618178A2 (en) | 2006-01-25 |
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