New method of regenerative medicine to treat ischemic heart disease makes clinical progress
【Technological frontier】
Guangming Daily, Beijing, September 13 (Reporter Qi Fang)
Myocardial infarction is a heart disease that seriously threatens human health. Although timely medical treatment, percutaneous coronary intervention, coronary artery bypass grafting and other treatments can save some Patients with myocardial infarction live, but there is still a lack of effective treatments for severe and old myocardial damage.
The Dai Jianwu Regenerative Medicine team from the Institute of Genetics and Developmental Biology of the Chinese Academy of Sciences collaborated with the team of Professor Wang Dongjin from Nanjing Gulou Hospital to carry out the world's first clinical study of injectable collagen scaffold material combined with stem cell transplantation to treat ischemic heart disease.
On September 10, the research team published relevant research results online in the academic journal "Journal of the American Medical Association": Since March 2016, it has begun to recruit patients with old myocardial infarction, and passed 44 cases of enrolled subjects for one-year Follow-up results showed that cell and material transplantation is safe. Collagen material combined with stem cell transplantation can significantly reduce the patient’s heart infarct volume after one year, and improve the patient’s quality of life and cardiac rating. It is very important for the preoperative condition (heart ejection). The effect is particularly obvious for patients with a score less than 40%).
Dai Jianwu introduced that stem cells have self-renewal and differentiation potential, as well as powerful nutrition and secretion functions. Stem cell transplantation is a research hotspot in the field of myocardial regeneration, but its therapeutic effects are still controversial.
Some studies have shown that stem cells are easy to spread after transplantation, and it is difficult to colonize and survive the injury site, which affects the therapeutic effect.
Therefore, how to promote the colonization of stem cells in the myocardial injury site is a key issue that needs to be resolved in stem cell therapy.
The research team led by Dai Jianwu has been engaged in the research of functional biomaterials for regenerative medicine for a long time. After years of research, they have successfully developed a collagen scaffold with good biocompatibility that can be used for intramyocardial injection, which can provide stable extracellular matrix support for cells. After being injected into the damaged myocardial tissue, it can effectively limit the spread of cells from the injured site and help remodel the myocardium to regenerate and repair the microenvironment.
At present, this material has completed product standardization research, and obtained product technical requirements certification, biosafety testing, immune evaluation, virus inactivation testing and other reports from authoritative institutions such as China Food and Drug Control Institute, reaching clinical implantable medical devices Quality Standard.
Dai Jianwu’s team cooperated with Wang Dongjin’s team at Nanjing Gulou Hospital to carry out preclinical large animal experiments to test the safety and effectiveness of materials and cell transplantation.
On the basis of obtaining clear safety and effectiveness evaluations in animal experiments, the team further formulated clinical trial plans, completed ethical review and international clinical research registration, and participated in the "Stem Cell and Regenerative Medicine Research" strategic leading technology project and key deployment of the Chinese Academy of Sciences With the funding of the project "Tissue and Organ Regeneration and Damage Repair", a randomized controlled clinical study of injectable collagen materials combined with umbilical cord mesenchymal stem cells for the treatment of ischemic heart disease was carried out.
The basic entry criteria for this clinical study are patients with old myocardial infarction who have a heart function of less than 45% and require bypass surgery.
After more than three years of hard work, the study enrolled a total of 50 patients and completed the 1-year follow-up of 44 patients. The results showed that cell and material transplantation are safe and effective in malignant events (death, tumor, persistent tachycardia). , Re-admission to hospital with heart failure, arrhythmia, etc.), the incidence, biochemical indicators, immune indicators, etc. were not significantly different from the control group.
Compared with the control group, collagen material combined with stem cell transplantation can significantly reduce the patient's heart infarction volume after one year, and improve the patient's quality of life and cardiac rating.
The effect is particularly obvious for patients with preoperative cardiac ejection fraction less than 40%: one year after the bypass and combined injection of stem cells and collagen materials, the cardiac ejection fraction increased by an average of 9.35%, while the control group increased to 6.59% (bypass surgery) Combined stem cell transplantation group) and 3.62% (bypass surgery group alone).
This is the first international clinical study of injectable scaffold material combined with stem cell transplantation for the treatment of ischemic heart disease. The study proved for the first time the clinical safety and feasibility of injectable material combined with stem cell for the treatment of heart disease, and showed The good application prospects laid the foundation for follow-up large-sample clinical trials.
"Guangming Daily" (Version 08, September 14, 2020)