Release date: 2017-10-11
Recently, good news came from the United States. Six of the six patients who suffered from spinal cord injury received a stem cell transplant for 1 year, and four of them showed significant improvement, including a significant improvement in arm mobility and basic behavioral abilities. This early clinical trial was conducted by the American stem cell company Asterias Biotherapeutics and was one of the first clinical trials to use embryonic stem cells in human trials.
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It is not yet certain that stem cells are fully responsible for patient improvement, but doctors and scientists involved in the trial say that the improvement in patients after stem cell therapy is significant compared to a large number of patients with similar spinal cord injuries.
There is currently no FDA-approved treatment for spinal cord injury, and patients can only recover through rehabilitation training. Richard Fessler, a principal investigator of the trial and a professor of neurosurgery at Loch University Medical Center in Chicago, believes that the results of this clinical trial give hope.
The beginning of treatment: embryonic stem cells to oligodendrocytes
This clinical trial uses embryonic stem cells. The embryonic stem cells were isolated from embryos produced by in vitro fertilization in 1998 and later devoted to scientific research. Animal experiments and in vitro experiments have found that oligodendrocyte precursor cells derived from these embryonic stem cells exhibit three potential repair functions at the site of spinal cord injury.
The project's scientists processed embryonic stem cells into oligodendrocyte precursor cells and transplanted them into the patient's spinal cord via a syringe.
Oligodendrocytes are a supporting cell that is responsible for the construction of myelin, which maintains the health and function of nerve cells. In spinal cord injury, many nerve cells are completely killed, and the myelin on the surviving cells is often destroyed, causing the body to lose its normal natural repair ability.
Without myelin, nerve cells cannot signal on the spine to control the movement or sensory function of the limbs and other parts of the body. Patients with severe spinal cord injuries also lose their ability to exercise and feel.
The method used in this clinical trial is believed to promote healing. Animal experiments have shown that transplanted cells can repair myelin itself and release chemicals that promote the body's self-healing.
The course of treatment: inject 10 million cells into the spinal cord
Prior to this trial, another company, Geron Corp., had investigated the treatment of spinal cord injury by transplanting 2 million cells. It was found that although this dose was sufficient to test the safety of stem cell transplantation, it was not sufficient to explore the improvement of patients' function.
This clinical trial is a dose escalation trial and is expected to include 35 patients in five echelons. The trial found that a dose of 10 million cells was sufficient to explore the therapeutic effect. The patient received treatment within 1-2 months of injury and this period is considered to be the best time to promote healing.
According to the latest results released by the Asterias research team, 67 patients had at least 2 levels of behavioral ability improved within 12 months after transplanting 10 million cells. Although the patients did not fully recover, the two grades of improvement meant that they were better able to use their hands and arms, and one of the patients had a great improvement in wearing clothes after treatment – ​​basically able to solve them themselves. . The trial found that the patient is still improving after one year of cell transplantation, which means that the transplanted cells are still healthy and functioning normally.
Christopher Block, a 31-year-old patient who participated in the trial, was injured in a bicycle accident in July 2016. He said that after receiving stem cell treatment for a month, he can eat himself and lift his left and right arms. After receiving treatment for more than a year in August 2016, he got rid of his wheelchair and was able to dress himself. Now he has been exercising and hopes to return to his normal life after one year. He said, "I am very excited to stand at the forefront of science!"
Next step: Conduct randomized controlled trials
Next, the research team plans to conduct a randomized controlled trial comparing patients receiving stem cell transplantation with those who did not receive stem cell transplantation but received the same care.
The researchers said they were prepared for the randomized controlled trial and were full of confidence. If subsequent clinical trials go well, they plan to push the therapy to the FDA approval stage.
Last Monday, Asterias also announced that they have received FDA-approved RMAT certification to accelerate their research and approval of stem cell therapies. Currently, only 5 or 6 have obtained this qualification, although it is not guaranteed to be approved by the FDA, it means that stem cell transplantation is very promising for spinal cord injury.
Reference material
[1]A New Cell Therapy Successfully RestoredMovement in Paralyzed Patients
[2] 'Superexciting' results in stem cell therapy trial
Source: Stem cells (micro signal stemcell8)
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