A kind of cell extract and application thereofTechnical field
The present invention relates to a kind of cell extract and application thereof, belong to medical domain.
Background technology
Retina is one of most sensitive organ in our bodies, is influenceed by most of chronic diseases, such as diabetes,Hypertension, dyslipidemia, autoimmune disease (SLE, hardening, amyloidosis), chronic infectious disease (TB- meningitis),And various gene defects and genetic disease.
Epidemiology survey shows, as an example of the problem of real depth, from the different patient's displaying one of three classesThe numeral of a little prevalence rates on retinal degenerative disease.The first kind is the genetic freak for influenceing retina.Retinal pigment becomesProperty and related rod-cone and retinal cone-rod dystrophy represent and cause most of illnesss of hypopsia and blindness.ArtLanguage retinal pigment degeneration represents a series of adverse reactions to a major class genetic disease.Can cause more than 190 genetic freaiesThe photosensitive exception of primary, some first can again influence cone or vice versa by influence retinal rod.The photosensitive abnormal illness rate of primary is 1:300-1:In the range of 5000, carrier state is about 1:100.
In other kinds of retinal degenerative disease, it has been found that the case load of America Diabetes PVR(as shown in Figure 1) increases to 7,690,000 in 2010 from 4,060,000 in 2000, it is contemplated that will be doubled to the year two thousand fifty.
The content of the invention
It is an object of the invention to be based on the particular peptide related to the generic and specific component and visual pathway of retina,A kind of medicine is developed, to help patient to recover eyesight, colour vision, the visual field and perception.
To achieve the above object, the technical scheme taken of the present invention is：A kind of cell extract, the cell extract bagInclude the low molecular weight peptide come from the organ specificity cell of animal, the organ specificity cell is from the device related to diseaseObtained in official or tissue.
As the further improvement to above-mentioned technical proposal, quality of the low molecular weight peptide in the cell extractPercentage composition is 30%.
Used as the further improvement to above-mentioned technical proposal, the molecular weight of the low molecular weight peptide is not more than 300K.
Used as the further improvement to above-mentioned technical proposal, the peptide is that the former peptide and molecular weight that molecular weight is less than 10K areThe composition of the peptide of 10K-300K.
Used as the further improvement to above-mentioned technical proposal, the animal is sheep.
Used as the further improvement to above-mentioned technical proposal, the organ specificity cell comes from foetal animal.It is above-mentionedThe organ specificity cell comes from the living cells of the aseptic extraction from new born sheep (0 years old) organ or tissue, filteringTo 300K. dalton.
Animal specification:(European Union's specification)
From closed colony, (its 20 generation ancestors do not have any rotavirus, genetic disease or any kind of cancer to 1-Disease)
2- animal doctor has to check for the time of animal birth, and provides health certificate.
The placenta of animal is checked after 3- births and is stored at 34 DEG C.
The laboratory for producing extract should be by GMP certifications.
Extract specification：It is aseptic；Filter to 300K. dalton；Toxin and microorganism testing；Active material concentration is30%.
Used as the further improvement to above-mentioned technical proposal, the disease is retinal degenerative diseases.
Used as the further improvement to above-mentioned technical proposal, the organ or tissue related to disease is selected from：After camera oculi posteriorHalf part, optic nerve, optic chiasma, the bottom of temporal lobe, cerebellum, occipital cortex, the 1/4 of prefrontal lobe.
Used as the further improvement to above-mentioned technical proposal, the retinal degenerative diseases include retinitis pigmentosaCaused retinal degeneration, senile retinal lesion, BDR, hypertensive retinopathy, itselfRetinosis complication, optic nerve malnutrition that immunity disease causes.
In addition, the present invention provides a kind of use of cell extract described above in retinal degenerative diseases are treatedOn the way.
Used as the further improvement to above-mentioned technical proposal, the usage of the extract is：Intramuscular injection, twice a week,Co-injection 10 weeks.
The beneficial effects of the present invention are：A kind of cell extract of the present invention, its organ for including coming from animalLow molecular weight peptide in specific cell, its organ specificity cell is obtained from the organ or tissue related to disease, describedExtract is aseptic, without toxin, biological safety preferably, and can help patient to recover eyesight, colour vision, the visual field and perception.
Brief description of the drawings
Fig. 1 is -2010 years 2000 case statistics column diagrams of America Diabetes PVR；
Fig. 2 is VEP Flash Test (VEP flash tests) figure；
Fig. 3 is ERG Photopic test (ERG adapts to optical tests) figure；
Fig. 4 is ERG Scotopic test (ERG is secretly tested) figure；
Fig. 5 is VEP Flash Test (VEP flash tests) figure；
Fig. 6 is ERG Scotopic test (ERG is secretly tested) figure；
Fig. 7 is ERG Photopic test (ERG adapts to optical tests) figure.
Specific embodiment
To better illustrate the object, technical solutions and advantages of the present invention, below in conjunction with specific embodiment and accompanying drawing pairThe present invention is described further.
The primary efficacy that embodiment 1 combines organ specific cell extract is tested
Carried out in two cases with reference to the primary efficacy test of organ specific cell extract, we will show two kindsThe case general introduction of situation and the curative effect of extract of the present invention, the result of wherein VEP Flash Test (VEP flash tests)As shown in Fig. 2 the result of ERG Photopic test (ERG adapts to optical tests) is as shown in figure 3, ERG Scotopic testThe result of (ERG is secretly tested) is as shown in Figure 4.
As we see in VEP tests, retinal function has slight improvement, without corresponding in retinal cortex pathImprove.
Typical case
15 years old male patients, just with serious amblyopia, (manually, left vision is 6/ to right eye before injection since infancy60), further, since related maculopathy, patient also suffers from serious yctalopia, and colour blindness simultaneously loses reading ability.
After patient signs Informed Consent Form and informs its all issuable side effect and complication in detail, note weeklyPenetrate the combination organ specific cell extract of 1.5m1 twice, co-injection 10 weeks.
Before injection, security test is carried out during and after, to prove that liver, kidney and blood picture are not subject to completelyInfluence.These security tests include:Whole blood mutually checks, full hepatoscopy (ALT, AST, bilirubin, albumin, AlzheimerDisease, PT, PTT) and holonephros inspection (Na-K-Cl- urea-kreatinin.
Symptom aspect, patient does not have any adverse reaction or any exception during injecting.Simultaneously also without any otherComplain.
When being expelled to the 3rd week, patient starts him and finds that his eyesight has some positive changes, and just looks at bookEasily.
We are with electroretinogram and VEP (VEP) is as tracking case and records except eyesight is accurately testedThe test of progress.
Combination organ specific cell extract of the present invention is injected after 10 weeks, patient's vision improves feelings and wishes as follows:
Zero right eye from bringing up to 1/60. manually
Zero left eye is from 6/60to 6/24.
Zero right eye from bringing up to 1/60. manually
Zero left eye brings up to 6/24. from 6/60
As shown in Fig. 5, Fig. 6, Fig. 7, wherein Fig. 5 is VEP Flash Test (VEP flash tests) figure for the change of VEP；Fig. 6It is ERG Scotopic test (ERG is secretly tested) figure；Fig. 7 is ERG Photopic test (ERG adapts to optical tests) figure.
Conclusion：For CMDA Retino earlier trials selected by the situation of the two cases represent heredity familyThe most more refractory case of property retinitis pigmentosa.It is believed that age related PVR and glycosuriaThe retinosis of the degeneration of the reversible of characteristic of disease PVR should show more preferable prognosis because in the absence of gene becauseSon.
Two cases show that its visual acuity and electroretinogram are significantly improved, and this reflects more retinal rods and cone cellRegeneration come into force.
The present inventors considered that in the 3rd case, should increase dosage effect dependence, they are prepared for nowIts file, because it is 3m1, twice a week, 10 weeks by a definite date that present inventor increases the dosage of CMDA Retino.
There is this positive result, this research recommendation carries out more other kinds of PVRs and different agentThe experiment of the retinitis of the active material of amount and various concentrations, so that we can reach optimal dose and preferred plan, makesPatient obtains optimal possible result.
It is last to should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention rather than the present invention is protectedThe limitation of scope is protected, although being explained in detail to the present invention with reference to preferred embodiment, one of ordinary skill in the art shouldUnderstand, technical scheme can be modified or equivalent, without deviating from the essence of technical solution of the present invention.