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New application of REGEND001 cell autotransfusion preparation

A cell and autologous technology, applied in the field of clinical medicine, can solve the problems of lack of alveolar structure, lack of conventional treatment methods, and failure to truly prevent fibrosis, etc., to achieve the effect of repairing lung damage and improving lung ventilation function

Pending Publication Date: 2022-01-18
REGEND THERAPEUTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

They have a certain delaying effect on the decline of lung function in patients, but it is difficult to improve lung function or reverse the course of the disease, and cannot really prevent the occurrence of fibrosis
At present, for IPF, except for whole lung transplantation, there is a lack of effective conventional treatment methods worldwide. The fundamental reason is that there is a lack of effective methods to regenerate and repair the damaged alveolar structure.

Method used

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  • New application of REGEND001 cell autotransfusion preparation
  • New application of REGEND001 cell autotransfusion preparation
  • New application of REGEND001 cell autotransfusion preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of autologous reinfusion preparation of REGEND001 cells

[0029] This embodiment provides a preparation process of clinical-grade autologous bronchial basal layer cells, which specifically includes the following steps:

[0030] The isolated active bronchi were collected for brush examination for later use. In this embodiment, the tissues located in two different parts of the bronchi were selected. The reason why two or more parts are selected is to ensure the success rate of separation.

[0031] Take the tissue digestion solution and stop solution for later use; 99v% of the tissue digestion solution is DMEM / F12, the rest is 1-20ng / mL DNase, 0.1-4mg / mL protease XIV and 10-200ng / mL trypsin; stop 90v% of the liquid is DMEM, and 10v% is FBS.

[0032] The above-mentioned brushed tissue is digested with the tissue digestion solution, and the digested tissue is terminated with the stop solution, and then the cells are collected. The cells after enzymat...

Embodiment 2

[0042] Example 2 Preparation of autologous reinfusion preparation of REGEND001 cells

[0043] This embodiment provides a preparation process of clinical-grade autologous bronchial basal layer cells, which specifically includes the following steps:

[0044] The isolated active bronchi were collected for brush examination for later use. In this embodiment, the tissues located in two different parts of the bronchi were selected. The reason why two or more parts are selected is to ensure the success rate of separation.

[0045] Take the tissue digestion solution and stop solution for later use; 99v% of the tissue digestion solution is DMEM / F12, the rest is 1-20ng / mL DNase, 0.1-4mg / mL protease XIV and 10-200ng / mL trypsin; stop 90v% of the liquid is DMEM, and 10v% is FBS.

[0046] The above-mentioned brushed tissue is digested with the tissue digestion solution, and the digested tissue is terminated with the stop solution, and then the cells are collected. The cells after enzymat...

Embodiment 3

[0057]Implementation 3 REGEND001 cell autologous reinfusion preparation for the treatment of idiopathic pulmonary fibrosis

[0058] 1) Specific steps:

[0059] ①The reinfusion sites are the lingual lobe of the left lung, the lower lobe of the left lung and the middle lobe of the right lung, and the 14 lung subsegments (segmental bronchi) of the lower lobe of the right lung, which are respectively the lateral segmental bronchi of the right middle lobe, the medial segmental bronchi of the right middle lobe, Right lower lobe apical bronchi, right inner basal bronchi, right anterior basal bronchi, right outer basal bronchi, right posterior basal bronchi, left upper lingual bronchi, left lower lingual bronchi, Left lower lobe apical bronchi, left anterior basal bronchi, left inner basal bronchi, left outer basal bronchi, and left posterior basal bronchi. The bronchi of the upper lobe of the left lung and the upper lobe of the right lung are not reinfused;

[0060] ②Take 14mL of t...

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Abstract

A traditional method for treating IPF mainly comprises the step of taking anti-inflammatory drugs and anti-fibrosis drugs, and the anti-inflammatory drugs and the anti-fibrosis drugs are not ideal in curative effect on middle and advanced fibrosis patients. In recent years, new drugs pirfenidone and nintedanib approved in China can only delay the disease progress and cannot improve the lung function or reverse the disease progress. The invention develops a bronchus basal layer cell product, namely a REGEND001 cell autotransfusion preparation. In the early exploratory clinical research, through local administration of an airway, the medicine is transfused to the body of a patient with idiopathic pulmonary fibrosis in an autotransfusion mode, and the medicine has the effects of repairing lung injury and improving the lung ventilation function.

Description

technical field [0001] The invention relates to the field of clinical medicine, in particular to a new application of REGEND001 cell autologous reinfusion preparation. Background technique [0002] Idiopathic pulmonary fibrosis (IPF) is a chronic progressive fibrotic interstitial pneumonia of unknown etiology. IPF has been included in the 2018 National List of Rare Diseases, and the number of cases in my country is increasing year by year. IPF tends to occur in middle-aged and elderly men, and is mainly manifested as progressive and aggravated dyspnea, accompanied by restrictive ventilatory dysfunction and gas exchange disorder, eventually leading to hypoxemia and even respiratory failure. The prognosis of IPF is poor, and its lung histology and chest high-resolution CT (HRCT) show general interstitial pneumonia (UIP), the main pathological features include diffuse alveolitis and pulmonary interstitial fibrosis, and its lung damage continues to progress , irreversible. Th...

Claims

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Application Information

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IPC IPC(8): A61K35/42A61P11/00A61P43/00
CPCA61K35/42A61K9/0019A61P11/00A61P43/00C12N5/0688C12N5/0689C12N2501/11C12N2500/40C12N2500/46C12N2501/33
Inventor 张婷
Owner REGEND THERAPEUTICS CO LTD
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