CN111467375A - Application of mesenchymal stem cells in preparation of medicine for treating rheumatoid arthritis - Google Patents
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Classifications
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- A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/01—Hydrolysed proteins; Derivatives thereof
- A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
Abstract
The invention discloses an application of mesenchymal stem cells in preparing a medicament for treating rheumatoid arthritis, wherein the mesenchymal stem cells are umbilical cord mesenchymal stem cells, the medicament also comprises cervus polypeptide and tanshinone IIA sodium sulfonate injection, the cervus polypeptide L G has the effects of tonifying kidney, strengthening bone, removing blood stasis, eliminating stagnation, removing dampness, and relieving pain, the tanshinone IIA sodium sulfonate injection DS is a fat-soluble effective active ingredient extracted from salvia miltiorrhiza, has the effects of promoting blood circulation, relieving pain, cooling blood, reducing swelling and the like, and the curative effect of treating RA by combining UC-MSC can be enhanced by adopting the early intervention of the kidney-tonifying and blood-activating traditional Chinese medicine injection L G + DS.
Description
Technical Field
The invention belongs to the field of rheumatism treatment, and particularly relates to application of mesenchymal stem cells in preparation of a medicament for treating rheumatoid arthritis.
Background
Rheumatoid Arthritis (RA) is a chronic, systemic autoimmune disease with erosive symmetric polyarthritis as the main clinical manifestation, with high disability rate. RA is distributed globally and is one of the main causes of loss of labor and disability of human beings. The prevalence rate of RA in China is about 0.32% -0.36%. Can occur at any age, 80% of the cases occur between 35 and 50 years of age, with female patients about 3 times as many as men. Clinically, it is manifested as symmetrical and persistent polyarthritis mainly involving the small joints such as the two hands and the wrist joint. The basic pathological changes in RA are synovitis, which is the basis of joint manifestations and the progressive destruction of articular cartilage and bone, ultimately leading to joint deformity and loss of function, and vasculitis. Vasculitis is the basis of extra-articular manifestations, occurring in any tissue outside the RA joint, involving the middle, small arteries and veins, with lymphocytic infiltration of the vessel wall, fibrin deposition, and hyperplasia of the intima, leading to narrowing or blockage of the vessel lumen. Vasculitis is one of the factors that make the prognosis of RA poor.
RA is related to inflammatory autoimmune diseases of multiple systems, the pathogenesis of RA is mainly immune effect disorder, and the problems of RA immune tolerance disorder and damaged joint tissue cell repair are difficult to solve by using the rheumatism guideline medicine. Clinical guidelines for RA use are mainly in the treatment of eliminating synovial inflammation and delaying progression of the disease, and it is difficult to overcome the lack of immune tolerance and repair of damaged joints in patients. Treatment of RA is a rheumatological challenge.
For a long time, rheumatism experts have designed a plurality of paradigms for treating rheumatoid diseases, but the diseases cannot be completely and effectively controlled by the experts. Traditionally, non-steroidal anti-inflammatory drugs and slow-acting antirheumatic drugs are mainly used, but the relapse rate of the disease is high, the side effect is obvious, and the progress of the disease cannot be changed; the biological treatment method aiming at the cytokine targeting therapy developed in recent years, but the use of biological agents easily increases the occurrence of various postoperative infections, has no obvious repair capability on damaged joints, and is expensive, thereby limiting the clinical use thereof. Patients with this type of rheumatism still face pain, death, disability, economic loss and drug intoxication, the five "D" factors. In the face of RA pain, the body and mind of a patient are afflicted, and the long-term severe reality of economic loss of individuals and countries is achieved. Therefore, it is very important to find a medicine or a treatment method which can effectively relieve the joint damage, dysfunction and other symptoms of RA patients, and achieve the purposes of relieving the disease condition and reducing the disease activity.
Disclosure of Invention
The invention aims to provide application of mesenchymal stem cells in preparing a medicament for treating rheumatoid arthritis.
In order to solve the technical problems, the invention discloses application of mesenchymal stem cells in preparing a medicament for treating rheumatoid arthritis.
Preferably, the mesenchymal stem cell is an umbilical cord mesenchymal stem cell.
Preferably, the medicine also comprises cervus and cucumis polypeptide and tanshinone IIA sodium sulfonate injection.
The invention also discloses a medicament for treating rheumatoid arthritis, which comprises umbilical cord mesenchymal stem cells.
The invention also discloses a third medicament for treating rheumatoid arthritis, which comprises umbilical cord mesenchymal stem cells, cervus and cucumis polypeptide and tanshinone IIA sodium sulfonate injection.
Compared with the prior art, the invention can obtain the following technical effects:
1) the invention discloses an application of mesenchymal stem cells in preparing a medicament for treating rheumatoid arthritis. The umbilical cord mesenchymal stem cells solve the fundamental problems of repairing damaged cells, recovering cell tissue functions and improving immune disorder for rheumatoid arthritis patients.
2) The cervus and cucumis polypeptide L G has the effects of tonifying kidney, strengthening bone, removing blood stasis, resolving hard mass, removing dampness and relieving pain, and the tanshinone IIA sodium sulfonate injection DS is a fat-soluble effective active ingredient extracted from the salvia miltiorrhiza and has the effects of promoting blood circulation, relieving pain, cooling blood, diminishing swelling and the like.
Detailed Description
The following embodiments are described in detail with reference to the accompanying drawings, so that how to implement the technical features of the present invention to solve the technical problems and achieve the technical effects can be fully understood and implemented.
The invention provides an application of Umbilical cord mesenchymal stem cells (UC-MSC) in preparing a medicament for treating rheumatoid arthritis, wherein the Umbilical cord mesenchymal stem cells have the biological characteristics of regeneration and repair of parenchymal tissue organs and immunoregulation.
In the present invention, umbilical cord mesenchymal stem cell UC-MSC is derived from human umbilical cord in gestational period. The UC-MSC has sufficient sources, convenient material taking, no limitation of ethics and laws, biological characteristics of self replication, directional differentiation, low immunogenicity, abundant immunocompetent cells and the like, and provides favorable support for clinically applying the UC-MSC to treat RA.
In the specific implementation process of the invention, the preferred method for obtaining umbilical cord mesenchymal stem cells UC-MSC is to obtain human umbilical cords of term pregnancy under aseptic condition, and then obtain the UC-MSC by purifying and culturing in an incubator in sequence.
The invention is not limited to the dosage form and the auxiliary materials of the medicine, and the appropriate auxiliary materials can be selected according to the dosage form of the medicine.
The UC-MSC injection used in the experiment of the invention is a patent product provided by Tianjin and Zebra stem cell technology limited company.
According to the theory of traditional Chinese medicine, kidney deficiency and blood stasis are the main causes and pathogenesis of RA, and the functions of tonifying kidney, strengthening bone, promoting blood circulation and removing obstruction in channels are the main treatment methods for treating RA. Clinical researches also show that the kidney tonifying and blood circulation activating can effectively improve the disturbance of the immune indexes of RA patients, has better curative effects on improving the symptoms of the joint stiffness and pain of the patients, reducing the laboratory indexes such as blood sedimentation, C-reactive protein and the like, and embodies the comprehensive effect and the characteristic advantages of the traditional Chinese medicine for treating the disease. Modern research in traditional Chinese medicine also shows that the essence stored in the kidney can correspond to embryonic stem cells and other adult stem cells which are differentiated into various tissues and organs, and the stem cells have the attribute of congenital essence. The kidney-tonifying traditional Chinese medicine can maintain the number and the functional state of stem cells, and part of the kidney-tonifying and blood-activating traditional Chinese medicine can induce the directional differentiation of the stem cells.
The cervus and cucumis polypeptide (L G) and the tanshinone IIA sodium sulfonate injection (DS) are novel traditional Chinese medicines, have clear components and definite effects, are reasonably researched compared with traditional Chinese medicine decoction and other dosage forms, and are reliable and credible.
L G is a compound preparation, which is prepared from bones of Cervidae animal Cervus Nippon Temminck and dried mature seeds of Cucurbitaceae plant Cucumis melo by extracting respectively to obtain sterilized aqueous solution, and has effects of invigorating kidney, strengthening bone, removing blood stasis, eliminating stagnation, eliminating dampness, and relieving pain modern pharmacological research shows that L G mainly contains semen melo extract and bone-induced polypeptide biological factor, and has effects of inhibiting macrophage activation, reducing content of TNF-a, I L-6 and I L-1 in blood serum, inhibiting inflammatory cell infiltration of synovial tissue and pannus formation, relieving articular cartilage injury, and reducing synovial tissue hyperplasia.
The in vitro research shows that the salvia miltiorrhiza can inhibit the secretion of RA (RA F L Ss) fibroblast-like synovial cells (RA F L Ss) TNF-a to relieve joint inflammation and relieve bone and cartilage destruction.
Therefore, the Chinese medicinal injection cervus and cucumis polypeptide (L G) is selected to be used for treating arthritis, and the tanshinone IIA sodium sulfonate injection (DS) is selected to be used for treating vasculitis, and the action mechanisms of L G and DS are consistent with the pathological mechanism of RA, the combination of the two medicaments has strong pertinence and also corresponds to the pathological mechanism of RA, so that the two medicaments are combined for treating RA, namely treating both principal and secondary aspects of RA.
Therefore, the traditional Chinese medicine injection L G and DS with clear components and definite functions are selected to be combined so as to promote the superposition of the effects of tonifying the kidney, strengthening bones, promoting blood circulation and dredging collaterals, reduce the release of proinflammatory factors, play the biological characteristics of enhancing UC-MSC migration, homing, regeneration and restoration and immunoregulation while stabilizing the internal environment, and enable the UC-MSC to play the best effect in the microenvironment in vivo.
Clinical research
The medication scheme and the observation indexes are as follows:
UC-MSC treatment (control group) with cell number of 4 × 10 directly in stem cell infusion chamber under ECG monitoring7UC-MSC40ml (Tianjin and Zebra Stem cell technology Co., Ltd.) by intravenous infusion, and 2mg dexamethasone was given before infusion into the kettle or promethazine hydrochloride (patients with hypertension, diabetes basic disease not suitable for hormone administration) 12.5mg intramuscular injection for antiallergic.
The Chinese medicinal injection L G + DS + UC-MSC is prepared from 0.9% Na L100 ml + L G24 mg (Harbin Dayu medicinal industry), 5% GS100ml + DS 40mg (Shanghai first biochemical medicinal industry), and UC-MSC by intravenous drip for 1 time/day, continuously infusing for 7 days and 8 days, and directly infusing the UC-MSC with the cell number of 4 × 10 in a stem cell infusion room under the condition of electrocardiographic monitoring740ml of UC-MSC (Tianjin and Zea Stem cell technology Co., Ltd.). Dexamethasone was given 2mg in a kettle or promethazine hydrochloride (patients with hypertension, diabetes mellitus basic disease not suitable for hormone use) 12.5mg intramuscular injection anti-allergy prior to infusion.
Patients were evaluated 3, 6 months after treatment:
(1) and (3) safety evaluation: the adverse reactions of patients are recorded in each follow-up visit, and indexes such as liver and kidney functions, serum immunoglobulin, C3, C4, electrocardiogram, chest radiograph, blood pressure and the like are checked regularly to observe the adverse reactions and the outcome conditions thereof.
Adverse reaction does not occur in the treatment process, the blood test is conventional, and the functions of the liver and the kidney are not abnormal.
(2) And (3) evaluating clinical effectiveness: disease activity score for 28 joints (DAS28), health rating scale (HAQ), RA clinical remission criteria (ACR20 criteria). As shown in table 1.
TABLE 1 comparison of DAS28 score and HAQ score before and after treatment in two groups of patients
3 months after the treatment, △ P is less than 0.05
(3) Laboratory efficacy assessment: changes in serum ESR, CRP, RF, anti-CCP antibodies after 3 months of treatment. As shown in tables 2 and 3.
TABLE 2 CRP, ESR comparison before and after treatment of two groups of patients
3 months after the treatment, △ P is less than 0.05
TABLE 3 comparison of RF and anti-CCP before and after treatment for two groups of patients
3 months after the treatment, △ P is less than 0.05
Before UC-MSC treatment, L G and DS are firstly applied to tonify the kidney and activate blood circulation, the medicine is dripped for 7 days to improve the state of kidney deficiency and blood stasis, synovitis and vasculitis of RA are reduced, and then UC-MSC is transplanted into vein, and the result is observed for 3 months.
The results show that the improvement of the HAQ, DAS28, ESR, CRP, RF and anti-CCP antibody levels of a patient is obviously superior to that of a patient using a UC-MSC group alone (P is less than 0.05) after 3 months of treatment in the L G + DS combined UC-MSC group, and all reach the ACR20 standard, so that the treatment of the traditional Chinese medicine L G + DS combined UC-MSC has the important functions of rapidly promoting the reduction of inflammatory factors, regulating the immune function of disorder and improving microcirculation, is beneficial to the migration of the UC-MSC and the repair of damaged tissues, and improves the treatment effect.
The traditional Chinese medicine injection L G and DS are the achievements of modern scientific research of traditional Chinese medicines, have clear components and definite functions, and provide reliable data and credible conclusion for the clinical research of treating RA by cooperating with UC-MSC.
While the foregoing description shows and describes several preferred embodiments of the invention, it is to be understood, as noted above, that the invention is not limited to the forms disclosed herein, but is not to be construed as excluding other embodiments and is capable of use in various other combinations, modifications, and environments and is capable of changes within the scope of the inventive concept as expressed herein, commensurate with the above teachings, or the skill or knowledge of the relevant art. And that modifications and variations may be effected by those skilled in the art without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (5)
1. Application of mesenchymal stem cells in preparing a medicament for treating rheumatoid arthritis.
2. The use of claim 1, wherein the mesenchymal stem cell is an umbilical cord mesenchymal stem cell.
3. The use as claimed in claim 1 or 2, wherein the medicament further comprises cervus polypeptide and tanshinone IIA sodium sulfonate injection.
4. A medicine for treating rheumatoid arthritis is characterized by comprising umbilical cord mesenchymal stem cells.
5. A medicine for treating rheumatoid arthritis is characterized by comprising umbilical cord mesenchymal stem cells, cervus and cucumis polypeptide and tanshinone IIA sodium sulfonate injection.
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| CN202010351325.XA CN111467375A (en) | 2020-04-28 | 2020-04-28 | Application of mesenchymal stem cells in preparation of medicine for treating rheumatoid arthritis |
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Cited By (1)
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| WO2022056991A1 (en) * | 2020-09-16 | 2022-03-24 | 生物岛实验室 | Mesenchymal stem cells derived from umbilical cord, and preparation method therefor and use thereof |
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| CN105154395A (en) * | 2015-09-28 | 2015-12-16 | 丛秀丽 | Preparing method for clinic level cells for enhancing immune modulating function of MSCs |
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| WO2022056991A1 (en) * | 2020-09-16 | 2022-03-24 | 生物岛实验室 | Mesenchymal stem cells derived from umbilical cord, and preparation method therefor and use thereof |
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