Post by imz72 on Jan 17, 2018 8:43:57 GMT
1st serious reaction to iPS-derived retinal cell transplant reported
KYODO JAN 17, 2018 KOBE
A patient who received a transplant of retinal cells derived from so-called iPS cells from another person has suffered a swollen retina, the team implementing the world's first clinical trials of the procedure said Tuesday.
It is the first time that a patient has developed a serious adverse reaction during the clinical research to assess the feasibility of using the artificially derived induced pluripotent stem cells, said the team consisting of the Kobe City Medical Center General Hospital and the government-backed Riken institute.
The patient in his 70s had an operation on Monday to remove preretinal membrane, deemed to be one of the causes of retinal edema, as the team was unable to improve the symptoms despite the administration of steroid and anti-vascular endothelial growth factor medication.
"We cannot deny the causal correlation with iPS cells," Masayo Takahashi, a researcher at Riken who heads the team, said at a press conference.
Takahashi said the symptom "falls into the category of serious cases" as it requires hospital admission for treatment but it is "neither a matter of great urgency nor life-threatening."
She said the incident should not affect the future process of the clinical study of transplantations of iPS-derived retinal cells in patients with severe eye disease.
The patient underwent the transplant in June to treat exudative age-related macular degeneration, a vision-threatening disease, at the hospital in Kobe. It was the second case of such a transplant of iPS-derived cells. His condition improved after the removal of preretinal membrane, the team said.
The team believes the edema was caused by a reversed flow of liquid solution containing retinal cells derived from iPS cells which were injected. The development of edema does not signify a rejection of iPS cells or its by-effects and there is room for improvement in the prevention of the backward flow, the team said.
For the clinical study, the team conducted the first such transplant surgery on a man from Hyogo Prefecture in March and announced in November the completion of the planned five procedures.
All of the operations were conducted using iPS cells, kept at Kyoto University, which were created to have an immune system that did not cause strong refusal responses.
"This case is not so serious, as there would remain not much problem as long as preretinal membrane is removed in a surgery," said Noriyuki Azuma, chief of the visual science laboratory at the National Center for Child Health and Development.
"It would not put a brake on regenerative medical techniques," he said, adding that it would be important to thoroughly check the preretinal membrane taken from the patient to find the cause of the adverse reaction.
The research team made the announcement in accordance with the law requiring medical institutions to report to the Minister of Health, Labor and Welfare a patient's illness or worsening condition suspected to have been caused by regenerative medical techniques that the person took.
japantoday.com/category/national/1st-serious-reaction-to-ips-derived-retinal-cell-transplant-reported
KYODO JAN 17, 2018 KOBE
A patient who received a transplant of retinal cells derived from so-called iPS cells from another person has suffered a swollen retina, the team implementing the world's first clinical trials of the procedure said Tuesday.
It is the first time that a patient has developed a serious adverse reaction during the clinical research to assess the feasibility of using the artificially derived induced pluripotent stem cells, said the team consisting of the Kobe City Medical Center General Hospital and the government-backed Riken institute.
The patient in his 70s had an operation on Monday to remove preretinal membrane, deemed to be one of the causes of retinal edema, as the team was unable to improve the symptoms despite the administration of steroid and anti-vascular endothelial growth factor medication.
"We cannot deny the causal correlation with iPS cells," Masayo Takahashi, a researcher at Riken who heads the team, said at a press conference.
Takahashi said the symptom "falls into the category of serious cases" as it requires hospital admission for treatment but it is "neither a matter of great urgency nor life-threatening."
She said the incident should not affect the future process of the clinical study of transplantations of iPS-derived retinal cells in patients with severe eye disease.
The patient underwent the transplant in June to treat exudative age-related macular degeneration, a vision-threatening disease, at the hospital in Kobe. It was the second case of such a transplant of iPS-derived cells. His condition improved after the removal of preretinal membrane, the team said.
The team believes the edema was caused by a reversed flow of liquid solution containing retinal cells derived from iPS cells which were injected. The development of edema does not signify a rejection of iPS cells or its by-effects and there is room for improvement in the prevention of the backward flow, the team said.
For the clinical study, the team conducted the first such transplant surgery on a man from Hyogo Prefecture in March and announced in November the completion of the planned five procedures.
All of the operations were conducted using iPS cells, kept at Kyoto University, which were created to have an immune system that did not cause strong refusal responses.
"This case is not so serious, as there would remain not much problem as long as preretinal membrane is removed in a surgery," said Noriyuki Azuma, chief of the visual science laboratory at the National Center for Child Health and Development.
"It would not put a brake on regenerative medical techniques," he said, adding that it would be important to thoroughly check the preretinal membrane taken from the patient to find the cause of the adverse reaction.
The research team made the announcement in accordance with the law requiring medical institutions to report to the Minister of Health, Labor and Welfare a patient's illness or worsening condition suspected to have been caused by regenerative medical techniques that the person took.
japantoday.com/category/national/1st-serious-reaction-to-ips-derived-retinal-cell-transplant-reported