China has a high caesarean section rate, and the uterus will be scarred after surgery, which poses a risk to future reproduction. How can this risk be reduced or even eliminated? Recently, a symposium on clinical trial protocols for surgical biological mesh for the prevention of hysterectomal defects (CSD) after caesarean section was held in Hangzhou. Clinical experts will use soft tissue inducible biomaterials independently developed by Shanghai enterprises to carry out regenerative repair tests for uterine incisions in caesarean section to escort pregnant women to give birth to second and third births.
This clinical trial stems from a heart-wrenching case. In September last year, a pregnant woman who was pregnant with her second child came to the Obstetrics and Gynecology Hospital affiliated to Zhejiang University School of Medicine, when she was 24 weeks pregnant, and the obstetric examination showed that there was a local loss of the muscle layer nearly 5 centimeters wide at the cesarean section of her lower uterus. To avoid a ruptured uterus, doctors advised her to terminate the pregnancy. However, the pregnant woman was desperate to keep the baby and begged the doctor to think of a way.
So she began to receive hospital observation, and had a B ultrasound test every 3 days. As the 26th week of gestation enters, the situation becomes increasingly dangerous – as the fetus develops, the uterus splits to 5×12 centimeters, one of the fetus's feet is already outstretched, and if he kicks the membranes, both mother and child will be in danger of life.
Dr. Feng Yan, a member of Professor Wang Zhengping's team, introduced the first case of soft tissue inducible biomaterial patch repair of hysterical incision scar cracking.
Surgery must be performed immediately! Previously, Professor Wang Zhengping led by Professor Wang Zhengping of the Affiliated Obstetrics and Gynecology Hospital of Zhejiang University School of Medicine has consulted a large number of literature and decided to use the soft tissue inducible biological material patch developed by Shanghai Songli Biotechnology Co., Ltd. to carry out uterine muscle repair surgery during pregnancy. The operation was a success, and on the third day after the operation, ultrasound B showed that a 2.5 mm muscle layer had grown at the crack, allowing the baby to continue to develop in the uterus. Nearly 35 weeks of gestation, the medical team performed a caesarean section on the mother, the mother and baby were safe, and the first biological patch repair of the pregnant uterine surgery in the mainland was successful.
Wang Zhengping's team found in the caesarean section that the integrity and firmness of the uterine muscle layer repaired with biological patches were very good. During the caesarean section, they also implanted a soft tissue induced biomaterial patch at the uterine incision of the pregnant woman to improve the safety factor for the future birth of three children.
He Hongbing, chief scientist of Songli Biology, introduced that the soft tissue inducible biomaterial platform technology independently developed by the company can be used to repair soft tissue in various parts of the body, and a number of clinical studies are underway. The successful surgical success of the zhejiang pregnant woman case has injected confidence into the project advancement, and the expert team is about to launch a randomized, controlled, multi-center clinical trial.
Soft tissue-inducible biomaterial magnified 20,000 times under electron microscopy
"The use of surgical biological mesh is of great significance for the regenerative repair of uterine incisions in caesarean section." Wang Zhengping said that in the context of the three-child policy, the issue of fertility risk has attracted attention, and the healing of the uterine incision of caesarean section is generally scar healing, rather than muscle healing, and the uterine scar is at risk of rupture when pregnant again. Statistics show that after 1-3 caesarean sections, the incidence of uterine incision defects reached 61%, 81%, and 100%, respectively. "The high incidence is due to the fact that healing at the incision in the uterine wall after surgery is scar healing." Yang Ming, director of Songli Biomedicine, said.
According to reports, the soft tissue inducible biomaterial developed by Songli Bio can induce the regeneration of smooth uterine muscle, and implanting this biological material in the uterine incision of caesarean section will form physiological muscle repair rather than scar repair. This biological material is a regenerative film made of electrospinning technology with natural polymer material - pig-derived fibrinogen as the main raw material, which has super hydrophilic properties. When implanted in the human body, it activates the immune response, initiates a remodeling response, and induces in-situ regeneration of soft tissues.
The ASTM F 3515-21 standard guidelines for the pig-derived fibrinogen standard, which was developed by the company, was approved by the American Institute of Test materials (ASTM) last year, becoming the first Chinese biomedical company to lead the development of ASTM standards. This original platform technology can be widely used in skin regeneration repair, intestinal anastomosis repair, esophageal hiatal hernia repair and other surgeries. The heavy tree composite hernia repair patch spawned by the platform technology has been approved by the State Food and Drug Administration for the regenerative repair of hernia.
Wang Zhengping said that animal experiments for regenerative repair of uterine incisions for caesarean section have achieved the expected results, and if the clinical trial is successful, it will be an important breakthrough in the field of perinatal medicine and bring good news to the majority of pregnant women.