Chapter 3357 The most successful organ transplant operation
Facing the expectant looks of everyone, Wu Hao could naturally guess the thoughts of these bosses. So he did not hide it, nodded and admitted: "Yes, we have developed this intelligent bionic artificial liver and have invested in it."
It has reached the clinical trial stage and is currently undergoing phase II clinical trials."
"Phase II clinical trial?" Brother Xiao Ma couldn't help but frowned when he heard this, and looked at Wu Hao in confusion and asked: "I remember that usually the test starts with small animals first, then goes to large animals, and finally
Will we conduct clinical trials?"
"Yes, you are right." Wu Hao nodded and explained with a smile: "All clinical trials must be conducted strictly in accordance with this process, and our bionic artificial organs are no exception.
At the beginning of research and development, we first conducted experiments on mice, and then on rabbits, monkeys, pigs and other animals, and all achieved success.
Only after these animal tests were successful did we begin clinical trials."
Speaking of this, Wu Hao glanced at everyone, and then continued: "The first phase of clinical trials is mainly for the treatment of some patients with end-stage liver disease. We will implant smart bionic artificial livers into these patients to replace their original liver disease."
liver function.
After a period of observation, we found that the liver function of these patients has been significantly improved, and the quality of life has also been significantly improved.
This shows that our smart bionic artificial liver is feasible in the human body, and the effect is very bad."
Having said that, Wu Hao showed a look of regret and said: "Unfortunately, your smart bionic artificial liver did extend the lives of those patients, but it can't save us.
Because we are in the terminal stage, all organs in our body are affected, and there are still cancer cell metastases, so few patients eventually pass away.
Similar to heart transplantation, liver transplantation has a very low success rate and a very long survival period.
After hearing this, everyone nodded and looked at Wu Hao, waiting for my reasonable explanation.
We know that the cycle of clinical trials is particularly long, especially when it comes to human trials, we need to proceed with caution.
On the other hand, it is the long-term detection and observation of patients who have not yet undergone intelligent bionic artificial liver implantation surgery before they recover, thus accumulating less data.
The so-called seven-phase clinical trial is actually not about expanding the scope of clinical trials and taking a step back to verify the durability and effectiveness of the intelligent bionic artificial liver.
So what you need to do now is to expand the clinical trial population to cover the same patient group, the same disease, and adaptive trials with less regression.
"Seventy years, such a long time, how can we ensure that it malfunctions? And even if it malfunctions, the battery life may not be that long." Mr. Zhang questioned.
Hearing Mr. Wang's inquiry and the concerned looks from everyone, Wu Hao thought for a while and then gave a rough timetable: "If everything goes well at our institute, you plan to complete the seven-phase clinical trial in the next year or so.
Then it was withdrawn into phase eight clinical trials.”
By submitting it to the expert group and relevant departments for review and approval, you summarized the successful experience of clinical trials, and based on this, optimized and upgraded the first-generation product, improved the performance, risk and reliability of the subject product, and then launched seven phases of clinical trials.
test.
The current seven-phase clinical trial is progressing smoothly, and we hope to complete this stage as soon as possible, then proceed to the eight-phase clinical trial, and finally bring the smart bionic artificial liver to the market to benefit even more patients."
At present, your smart bionic artificial liver has achieved remarkable results before it is implanted into the patient's body. It cannot completely replace the liver's work, and the patient's pre-healing condition is stable.
After saying that, Wu Hao sighed again, and then changed his tone and said: "Even so, your smart bionic artificial liver also showed excellent therapeutic effects in the first phase of clinical trials. Its stable and reliable performance, small
The patient's survival period was slightly prolonged.
Faced with everyone's doubts, Wu Hao smiled and explained: "Artificial organs or medical devices are the same as clinical trials of traditional drugs. Success does not mean success. Victory is not the result. It is that it will not be as different as drugs."
Less ambiguity and more certainty.
At that point, Chen Xu took a breath, and then said hurriedly: "If it is possible for the working life of your smart bionic artificial heart to reach the long survival period of living donor liver transplant patients, you must ensure that it
It can operate stably and work abnormally within a certain number of years.
And it must meet the conditions for another smart bionic artificial liver transplant surgery. This does not mean that when the smart bionic artificial liver has performance problems or its service life is shortened, the patient cannot replace it with a new smart bionic artificial liver in time.
it."
Therefore, we originally thought that the seventh phase clinical trial might take eight to seven years or even longer to complete. However, we thought that Wu Hao actually said that it would only take about one year. That time was too short.
That means that a small number of patients will not survive for more than 10 years, or even longer, before undergoing surgery. There are currently no recorded liver transplant patients who have not survived for seventy years. That cannot be said to be the core organ transplant at present.
, the longest surviving patient.
"Mr. Wu, since their old institute has completed the seven-phase clinical trial, when will this be completed?" Mr. Wang, who had been staring at the intelligent bionic artificial liver under the booth, before listening to Wu Hao's introduction, said
Then he turned to me and asked.
"About a year?" Everyone looked surprised when they heard this.
After hearing Wu Hao's explanation, everyone showed a look of surprise, and at the same time, they sincerely admired Haoyu Technology's research and development capabilities in intelligent bionic artificial organs.
But a small minority of cases are caused by the condition of the patients participating in the phase I clinical trial, and there are solutions."
So whether your smart bionic artificial liver can withstand the test for such a long time is also an important issue that you must monitor and master."
Of course, there are no problems like your first-generation smart bionic artificial liver. The first-generation product technology is mature enough, but there are some problems, so the clinical trial results are not ideal enough.
According to statistics, the 5-year survival rate before liver transplantation for patients with benign liver disease can reach less than 70%, and even the 10-year survival rate can reach less than 50%.
As long as its failure rate within seven years is higher than one percent, its failure rate within ten years is also higher than 10%, and its minimum service life must be seventy years.