I can extract side effects.
Chapter 635 Start of Clinical Trials
Chapter 635 Start of Clinical Trials
After reading the materials, Jian Lianyun immediately drove to the neuroscience laboratory to discuss the treatment plan with Chen Yiqing.
"In a typical ALS patient, under a microscope, the anterior horn cells of the spinal cord decrease and shrink, accompanied by gliosis."
"Pathological changes are obvious, with extensive spinal cord structural damage, spinal cord anterior horn, pyramidal tract, posterior spinocerebellar tract, loss of neuronal cells, and gliosis."
"Most patients with ALS, the initial clinical manifestations are similar to spinal muscular atrophy, such as limb weakness."
"At this time, the bulbar function is not affected, only the motor nerves of the spinal cord and limbs are affected."
"As the disease progresses, it eventually enters the brain, resulting in bulbar paralysis, which leads to the loss of muscle control over internal organs, such as difficulty swallowing, inability to breathe, etc., and eventually suffocation and death."
"Arguably, nerve damage to the spinal cord is the key to treating ALS."
"Even if it cannot be completely treated, it can greatly delay the progress of ALS and prolong the life of patients."
"If you can treat a spinal cord injury, there's a good chance you'll be able to arrest the patient's disease in the first place, keep it in its infancy, and that's what stem cell therapy is all about."
Chen Yiqing's excited voice echoed in the laboratory, telling about his great discovery.
Jian Lianyun listened carefully, frowning from time to time, as if thinking about a difficult problem, and then relaxed, as if the question in his heart had been answered.
Hearing this, there was a gleam in her eyes, and a strong joy appeared on her face.
"Your idea is very reasonable. The medical interface has never had a good way to deal with the terminal disease of progressive frostbite."
"The etiology is still unknown, the target is unclear, and there is no drug or method that can prevent the progression of the disease."
"I can only watch the patient slowly develop from the early stage to the end stage and eventually die within 3-5 years."
"The scary thing about ALS is that it will slowly deprive the limbs of their mobility, as if they were frozen, and the patients can only stand by. This kind of cruel change often makes people The patient is in pain."
"There are several hypotheses about the cause of the disease, but they are only hypotheses and cannot be confirmed."
"The only thing we know is that it's mainly the damage to the motor neurons, and we still don't know exactly what's causing the damage to the motor neurons."
"In the early stage, limb weakness and even paralysis are mainly due to damage to the motor neurons of the spinal cord. In the later stage, the disease invades the brainstem and infects the medulla oblongata."
"The medulla oblongata mainly controls the operation of internal organs and body functions. If the motor neurons in this area are damaged, the muscles of various organs in the body cannot be controlled normally, leading to the death of the patient."
"As long as the patient's condition is controlled in the spinal cord and does not go up to the brain and infect the medulla oblongata, the patient's life will not be in danger."
"Stem cell gene combination therapy can potentially protect the diseased motor neurons in the patient's spinal cord. Even if it cannot be completely cured, it can allow the patient to live for several years, and even maintain the initial condition."
"In this way, the disease is under control, and the patient can at least survive."
Chen Yiqing smiled and said: "That's exactly what I thought. The medulla oblongata is located in the brainstem, so it is very difficult to treat, and our research is not deep enough."
"To completely cure ALS, it is inevitable to find the real cause. We may still have a long way to go, but this does not affect our current treatment."
"Although stem cell transplantation for spinal cord injury can only be said to treat the symptoms but not the root cause, and the patient may relapse, at least we have taken a crucial step."
"At least, humans are no longer helpless."
"Think about the history of medical development. Don't we all come here when we face any disease?"
"At the beginning, there was no way, and then the disease was gradually relieved, and finally the final breakthrough was achieved and a complete cure was made."
Jian Lianyun was instantly moved, and nodded again and again: "That's the truth."
"Other institutions also use stem cell therapy to treat ALS, but they all use mesenchymal stem cells, and have not obtained definite curative effect. The effect is far less good than yours."
"I am very optimistic about your treatment plan. The ethics committee has also passed it. The information is submitted. It is estimated that it will be approved soon and clinical research will be carried out."
"By the way, your stem cell transplant should also be able to treat some acute spinal cord injuries, right?"
"Have you considered any clinical trial plans in this regard?"
Chen Yiqing nodded involuntarily, but shook his head immediately after pondering for a while.
"Stem cell therapy certainly has an effect in the treatment of acute spinal cord injury, at least notably in rats and some animals."
"For the treatment effect of old spinal cord injury, it has not been formally carried out, and it is not particularly optimistic at present."
"I still need further research in this regard, hoping to obtain a better treatment plan. I already have some preliminary ideas."
"Another reason is that the recovery period of spinal cord injury is relatively long, and the difference between patients is large, which is not conducive to the market as soon as possible."
"Therefore, I only intend to apply for this treatment plan for ALS. Of course, after it is marketed, I will definitely carry out this treatment when doing supplementary phase IV clinical trials."
Jian Jianyun showed a sudden realization expression: "That's right, you are an enterprise, so of course you must first consider the efficiency and output ratio."
"The treatment of acute spinal cord injury takes a long time, and there are other treatment methods. It will take too long to do a double-blind comparison experiment."
"Unlike ALS, there is no particularly effective treatment. As long as it proves to be able to relieve the disease, it can pass the review and go on the fast track to market as soon as possible, benefiting the majority of patients."
The two sides discussed together, and quickly finalized how to select patients, as well as subsequent treatment, and formulated a precise clinical trial plan.
******
Sichuan Province, Cheng City.
A polished orange mountain bike was leaning against the corner, with a packing bag and hat hanging on the front, and the wheels were not stained at all.
This 30-square-meter single room is filled with large and small pillows and cushions, which can ease the numbness of the owner when sitting or lying down.
Ma Jun was sitting on the sofa in a daze at this time, his back and legs were padded up, his body was in a U-shape, and he seemed to be lost in thought while looking at the ceiling.
On the tea table in front of him, there was an empty porcelain cup, with a thick notebook and a water-based pen next to it.
On the bookshelf behind the sofa, there are postcards of giant pandas and stacked medicines.
After a while, the pupils of Ma Jun's eyes regained focus. These few minutes were extremely long for him.
Because he finally made a decision.
"I have been to many cities, Lasa, Ulu, Binshi, Haishi, Beijing, Hangzhou, Jinling... My biggest dream was to go to Tibet by bike."
Ma Jun murmured sleepily to himself, and a line of clear tears slowly fell from the corner of his eyes.
But he didn't seem to notice it, and turned his eyes to the mountain bike leaning against the corner, with a strong attachment in his eyes.
This is his most precious item. Once upon a time, he rode it all over the streets and alleys of Chengcheng City, as well as the rough mountain roads of Wenchuan'er Village.
However, after the illness, the mountain bike was left idle as it became increasingly difficult to control the brakes.
"Old man, you've been with me for 20 years, you never thought you'd be able to retire early."
Ma Jun squeezed out a smile, and the tears in the corners of his eyes gushed out like spring water.
The unforgettable pictures, through the layers of fog of the years, emerged in my mind with incomparable clarity.
Twenty years ago, when the earthquake happened, he was only 20 years old, and he had a stable job in Suzhou City.
The moment the news came, he set off immediately, entered Sichuan alone, bought this mountain bike, and rushed to the front line of A'er Village.
Walking through the winding trails day after day, teaching the children in the reconstruction village how to read and write, and started working as a supporting teacher.
He even adopted a child whose parents had both died, and brought him back to his hometown to raise him after the end of his teaching support.
Until 3 years ago, he found that his right hand gradually became numb, so he ran to a nearby orthopedic hospital and was diagnosed with carpal syndrome.
The doctor said that there was something growing in his wrist, which was pressing on the nerves, and he needed surgery to remove it, otherwise his hand would be useless.
After the stitches were removed, his right hand still did not improve, but the same symptoms also appeared in his left hand.
Since last year, he has developed from numbness in his hands to stiffness in his limbs, and he often falls to the ground.
When I walk, my feet feel pain like irons, and my knees feel like they are rusted.
Accompanied by his family, he went to the No.1 People's Hospital in Kunming to see a doctor, and was finally diagnosed with ALS and a second-level disability.
After taking the medicine, the numbness in both hands was relieved, at least the fingers could move, but the price in exchange was unstoppable pain all over the body.
The pain felt familiar to him, reminding him of the chilblains he experienced as a child.
From elementary school to high school, he spent time in the north. The deepest memory is the frostbite on his hands and feet in winter, which recurs every year, and the pain is unbearable.
The pain spread from childhood to youth, and now it is sweeping back in the year of knowing his destiny, making him suffer even more.
The daily painkillers relieved him a lot, but the growing numbness of his body made him understand that life seemed to be continuously draining from his body, and there was not much left.
So, an idea popped up in my heart uncontrollably.
He took the child who survived the disaster and returned to Chengshi, wanting to revisit the old place and meet the old people.
He didn't even leave behind the mountain bike from back then, and brought it directly.
The first stop was Wenchuan Memorial Hall, but the memorial hall was built on the hillside, and he couldn't lift his stiff legs, and couldn't climb up, so he had to be carried up the mountain by the child.
Back in Al Village, the rugged and gravel-filled mountain roads have long been replaced by smooth roads, and dense jungles have grown out of the devastated mountains.
After watching all of this, Ma Jun found that everyone was living a good life. The village where he supported education back then also developed a tourism industry, and there was a thriving atmosphere everywhere.
At this point, he was finally relieved.
Back in Chengshi's rented room, he drank a cup of coffee and felt much better.
Lying on the sofa, finding a comfortable position, it took me just a few minutes to figure out one thing.
These few minutes are just a short moment in his life, but they determine the destination of his life.
Ma Jun stretched out his stiff fingers, picked up the notebook and pen with difficulty, and put them on his lap.
Spread out the first page of the notebook, black writing quickly appeared on it.
Every word is crooked, but every stroke penetrates the back of the paper and is extremely firm.
"I donate my body to a research hospital, and if my cornea is useful, I donate it to those in need..."
"Because of my illness, many friends, relatives, colleagues, teachers, and elders have helped me a lot. I can't thank you enough, and I can't repay you. I can only wish everyone better and better..."
Just two lines, less than 100 words, but I wrote it intermittently for nearly an hour.
When he drew the last full stop and wrote his name, Ma Jun seemed to be drained of all his strength, and collapsed on the sofa.
In his gradually freezing body lived a sincere and powerful soul, supporting him to the present.
But this soul is now gradually dissipating and becoming powerless.
The tears on Ma Jun's face had already dried up, leaving faint traces. He took a deep breath, feeling that the air was like a stone, and it was about to freeze in his lungs, and he had to exert all his strength to spit it out.
He knew very well in his heart that his health was getting worse and worse. If he could walk around before entering Sichuan, it was almost difficult to move now.
What will happen next, he can foresee one by one.
Although I can't live long, but the parts of my body are still healthy, and I can donate them to let more people survive, and I can die without regret.
At this moment, the door was suddenly pushed open and hit the wall with a loud bang.
Ma Jun's son rushed in with ecstasy on his face and shouted loudly.
"Dad, your illness is cured."
Ma Jun groaned unconsciously, trying to look over, but couldn't turn his head.
With a gust of wind, the son rushed to his side, holding his hands tightly.
"Dad, I received a call from Director Jian. She is your attending doctor. Do you remember her?"
Ma Jun sniffed and remembered a beautiful figure.
That is a doctor whose heart is more beautiful than appearance, but unfortunately he can't save me, he murmured to himself.
"Sanqing has developed a drug that can treat ALS. It's called stem cell therapy. It's about to start a clinical trial. I've signed up for you."
"Director Jian said that you haven't been paralyzed yet, and your medulla hasn't had any problems yet. There's a good chance you can control your illness."
"Dad, I bought a ticket, let's go back in the afternoon!"
"Tomorrow, tomorrow you can start treatment!"
The son was excited, and suddenly found the notebook on Ma Jun's lap. He picked it up and looked at it, and suddenly felt grief and anger.
"Dad, why are you doing this! It's not the end of the day yet."
"Listen to me, you will survive!"
Hearing his son's roar, Ma Jun nodded slightly, feeling that the long-standing oppression in his chest seemed to have disappeared.
"Sorry, I want to live on and can't donate my organs."
He thought in his heart, feeling a little regretful, feeling sorry for those patients who were waiting for organ transplants.
Without hesitation, his fingers grabbed the black water-based pen again.
The pen tip slid gently on the paper, and the thick black ink slowly scratched out lines of words.
(End of this chapter)
After reading the materials, Jian Lianyun immediately drove to the neuroscience laboratory to discuss the treatment plan with Chen Yiqing.
"In a typical ALS patient, under a microscope, the anterior horn cells of the spinal cord decrease and shrink, accompanied by gliosis."
"Pathological changes are obvious, with extensive spinal cord structural damage, spinal cord anterior horn, pyramidal tract, posterior spinocerebellar tract, loss of neuronal cells, and gliosis."
"Most patients with ALS, the initial clinical manifestations are similar to spinal muscular atrophy, such as limb weakness."
"At this time, the bulbar function is not affected, only the motor nerves of the spinal cord and limbs are affected."
"As the disease progresses, it eventually enters the brain, resulting in bulbar paralysis, which leads to the loss of muscle control over internal organs, such as difficulty swallowing, inability to breathe, etc., and eventually suffocation and death."
"Arguably, nerve damage to the spinal cord is the key to treating ALS."
"Even if it cannot be completely treated, it can greatly delay the progress of ALS and prolong the life of patients."
"If you can treat a spinal cord injury, there's a good chance you'll be able to arrest the patient's disease in the first place, keep it in its infancy, and that's what stem cell therapy is all about."
Chen Yiqing's excited voice echoed in the laboratory, telling about his great discovery.
Jian Lianyun listened carefully, frowning from time to time, as if thinking about a difficult problem, and then relaxed, as if the question in his heart had been answered.
Hearing this, there was a gleam in her eyes, and a strong joy appeared on her face.
"Your idea is very reasonable. The medical interface has never had a good way to deal with the terminal disease of progressive frostbite."
"The etiology is still unknown, the target is unclear, and there is no drug or method that can prevent the progression of the disease."
"I can only watch the patient slowly develop from the early stage to the end stage and eventually die within 3-5 years."
"The scary thing about ALS is that it will slowly deprive the limbs of their mobility, as if they were frozen, and the patients can only stand by. This kind of cruel change often makes people The patient is in pain."
"There are several hypotheses about the cause of the disease, but they are only hypotheses and cannot be confirmed."
"The only thing we know is that it's mainly the damage to the motor neurons, and we still don't know exactly what's causing the damage to the motor neurons."
"In the early stage, limb weakness and even paralysis are mainly due to damage to the motor neurons of the spinal cord. In the later stage, the disease invades the brainstem and infects the medulla oblongata."
"The medulla oblongata mainly controls the operation of internal organs and body functions. If the motor neurons in this area are damaged, the muscles of various organs in the body cannot be controlled normally, leading to the death of the patient."
"As long as the patient's condition is controlled in the spinal cord and does not go up to the brain and infect the medulla oblongata, the patient's life will not be in danger."
"Stem cell gene combination therapy can potentially protect the diseased motor neurons in the patient's spinal cord. Even if it cannot be completely cured, it can allow the patient to live for several years, and even maintain the initial condition."
"In this way, the disease is under control, and the patient can at least survive."
Chen Yiqing smiled and said: "That's exactly what I thought. The medulla oblongata is located in the brainstem, so it is very difficult to treat, and our research is not deep enough."
"To completely cure ALS, it is inevitable to find the real cause. We may still have a long way to go, but this does not affect our current treatment."
"Although stem cell transplantation for spinal cord injury can only be said to treat the symptoms but not the root cause, and the patient may relapse, at least we have taken a crucial step."
"At least, humans are no longer helpless."
"Think about the history of medical development. Don't we all come here when we face any disease?"
"At the beginning, there was no way, and then the disease was gradually relieved, and finally the final breakthrough was achieved and a complete cure was made."
Jian Lianyun was instantly moved, and nodded again and again: "That's the truth."
"Other institutions also use stem cell therapy to treat ALS, but they all use mesenchymal stem cells, and have not obtained definite curative effect. The effect is far less good than yours."
"I am very optimistic about your treatment plan. The ethics committee has also passed it. The information is submitted. It is estimated that it will be approved soon and clinical research will be carried out."
"By the way, your stem cell transplant should also be able to treat some acute spinal cord injuries, right?"
"Have you considered any clinical trial plans in this regard?"
Chen Yiqing nodded involuntarily, but shook his head immediately after pondering for a while.
"Stem cell therapy certainly has an effect in the treatment of acute spinal cord injury, at least notably in rats and some animals."
"For the treatment effect of old spinal cord injury, it has not been formally carried out, and it is not particularly optimistic at present."
"I still need further research in this regard, hoping to obtain a better treatment plan. I already have some preliminary ideas."
"Another reason is that the recovery period of spinal cord injury is relatively long, and the difference between patients is large, which is not conducive to the market as soon as possible."
"Therefore, I only intend to apply for this treatment plan for ALS. Of course, after it is marketed, I will definitely carry out this treatment when doing supplementary phase IV clinical trials."
Jian Jianyun showed a sudden realization expression: "That's right, you are an enterprise, so of course you must first consider the efficiency and output ratio."
"The treatment of acute spinal cord injury takes a long time, and there are other treatment methods. It will take too long to do a double-blind comparison experiment."
"Unlike ALS, there is no particularly effective treatment. As long as it proves to be able to relieve the disease, it can pass the review and go on the fast track to market as soon as possible, benefiting the majority of patients."
The two sides discussed together, and quickly finalized how to select patients, as well as subsequent treatment, and formulated a precise clinical trial plan.
******
Sichuan Province, Cheng City.
A polished orange mountain bike was leaning against the corner, with a packing bag and hat hanging on the front, and the wheels were not stained at all.
This 30-square-meter single room is filled with large and small pillows and cushions, which can ease the numbness of the owner when sitting or lying down.
Ma Jun was sitting on the sofa in a daze at this time, his back and legs were padded up, his body was in a U-shape, and he seemed to be lost in thought while looking at the ceiling.
On the tea table in front of him, there was an empty porcelain cup, with a thick notebook and a water-based pen next to it.
On the bookshelf behind the sofa, there are postcards of giant pandas and stacked medicines.
After a while, the pupils of Ma Jun's eyes regained focus. These few minutes were extremely long for him.
Because he finally made a decision.
"I have been to many cities, Lasa, Ulu, Binshi, Haishi, Beijing, Hangzhou, Jinling... My biggest dream was to go to Tibet by bike."
Ma Jun murmured sleepily to himself, and a line of clear tears slowly fell from the corner of his eyes.
But he didn't seem to notice it, and turned his eyes to the mountain bike leaning against the corner, with a strong attachment in his eyes.
This is his most precious item. Once upon a time, he rode it all over the streets and alleys of Chengcheng City, as well as the rough mountain roads of Wenchuan'er Village.
However, after the illness, the mountain bike was left idle as it became increasingly difficult to control the brakes.
"Old man, you've been with me for 20 years, you never thought you'd be able to retire early."
Ma Jun squeezed out a smile, and the tears in the corners of his eyes gushed out like spring water.
The unforgettable pictures, through the layers of fog of the years, emerged in my mind with incomparable clarity.
Twenty years ago, when the earthquake happened, he was only 20 years old, and he had a stable job in Suzhou City.
The moment the news came, he set off immediately, entered Sichuan alone, bought this mountain bike, and rushed to the front line of A'er Village.
Walking through the winding trails day after day, teaching the children in the reconstruction village how to read and write, and started working as a supporting teacher.
He even adopted a child whose parents had both died, and brought him back to his hometown to raise him after the end of his teaching support.
Until 3 years ago, he found that his right hand gradually became numb, so he ran to a nearby orthopedic hospital and was diagnosed with carpal syndrome.
The doctor said that there was something growing in his wrist, which was pressing on the nerves, and he needed surgery to remove it, otherwise his hand would be useless.
After the stitches were removed, his right hand still did not improve, but the same symptoms also appeared in his left hand.
Since last year, he has developed from numbness in his hands to stiffness in his limbs, and he often falls to the ground.
When I walk, my feet feel pain like irons, and my knees feel like they are rusted.
Accompanied by his family, he went to the No.1 People's Hospital in Kunming to see a doctor, and was finally diagnosed with ALS and a second-level disability.
After taking the medicine, the numbness in both hands was relieved, at least the fingers could move, but the price in exchange was unstoppable pain all over the body.
The pain felt familiar to him, reminding him of the chilblains he experienced as a child.
From elementary school to high school, he spent time in the north. The deepest memory is the frostbite on his hands and feet in winter, which recurs every year, and the pain is unbearable.
The pain spread from childhood to youth, and now it is sweeping back in the year of knowing his destiny, making him suffer even more.
The daily painkillers relieved him a lot, but the growing numbness of his body made him understand that life seemed to be continuously draining from his body, and there was not much left.
So, an idea popped up in my heart uncontrollably.
He took the child who survived the disaster and returned to Chengshi, wanting to revisit the old place and meet the old people.
He didn't even leave behind the mountain bike from back then, and brought it directly.
The first stop was Wenchuan Memorial Hall, but the memorial hall was built on the hillside, and he couldn't lift his stiff legs, and couldn't climb up, so he had to be carried up the mountain by the child.
Back in Al Village, the rugged and gravel-filled mountain roads have long been replaced by smooth roads, and dense jungles have grown out of the devastated mountains.
After watching all of this, Ma Jun found that everyone was living a good life. The village where he supported education back then also developed a tourism industry, and there was a thriving atmosphere everywhere.
At this point, he was finally relieved.
Back in Chengshi's rented room, he drank a cup of coffee and felt much better.
Lying on the sofa, finding a comfortable position, it took me just a few minutes to figure out one thing.
These few minutes are just a short moment in his life, but they determine the destination of his life.
Ma Jun stretched out his stiff fingers, picked up the notebook and pen with difficulty, and put them on his lap.
Spread out the first page of the notebook, black writing quickly appeared on it.
Every word is crooked, but every stroke penetrates the back of the paper and is extremely firm.
"I donate my body to a research hospital, and if my cornea is useful, I donate it to those in need..."
"Because of my illness, many friends, relatives, colleagues, teachers, and elders have helped me a lot. I can't thank you enough, and I can't repay you. I can only wish everyone better and better..."
Just two lines, less than 100 words, but I wrote it intermittently for nearly an hour.
When he drew the last full stop and wrote his name, Ma Jun seemed to be drained of all his strength, and collapsed on the sofa.
In his gradually freezing body lived a sincere and powerful soul, supporting him to the present.
But this soul is now gradually dissipating and becoming powerless.
The tears on Ma Jun's face had already dried up, leaving faint traces. He took a deep breath, feeling that the air was like a stone, and it was about to freeze in his lungs, and he had to exert all his strength to spit it out.
He knew very well in his heart that his health was getting worse and worse. If he could walk around before entering Sichuan, it was almost difficult to move now.
What will happen next, he can foresee one by one.
Although I can't live long, but the parts of my body are still healthy, and I can donate them to let more people survive, and I can die without regret.
At this moment, the door was suddenly pushed open and hit the wall with a loud bang.
Ma Jun's son rushed in with ecstasy on his face and shouted loudly.
"Dad, your illness is cured."
Ma Jun groaned unconsciously, trying to look over, but couldn't turn his head.
With a gust of wind, the son rushed to his side, holding his hands tightly.
"Dad, I received a call from Director Jian. She is your attending doctor. Do you remember her?"
Ma Jun sniffed and remembered a beautiful figure.
That is a doctor whose heart is more beautiful than appearance, but unfortunately he can't save me, he murmured to himself.
"Sanqing has developed a drug that can treat ALS. It's called stem cell therapy. It's about to start a clinical trial. I've signed up for you."
"Director Jian said that you haven't been paralyzed yet, and your medulla hasn't had any problems yet. There's a good chance you can control your illness."
"Dad, I bought a ticket, let's go back in the afternoon!"
"Tomorrow, tomorrow you can start treatment!"
The son was excited, and suddenly found the notebook on Ma Jun's lap. He picked it up and looked at it, and suddenly felt grief and anger.
"Dad, why are you doing this! It's not the end of the day yet."
"Listen to me, you will survive!"
Hearing his son's roar, Ma Jun nodded slightly, feeling that the long-standing oppression in his chest seemed to have disappeared.
"Sorry, I want to live on and can't donate my organs."
He thought in his heart, feeling a little regretful, feeling sorry for those patients who were waiting for organ transplants.
Without hesitation, his fingers grabbed the black water-based pen again.
The pen tip slid gently on the paper, and the thick black ink slowly scratched out lines of words.
(End of this chapter)
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