AMD

Allele-iPSC News Translate: iPS clinical research encounters a problem. Doctors say “the problem is not caused by iPSCs”

Kobe City Medical Center General Hospital and Riken Research Institute announced and reported to the Japanese government that a patient who had received allogeneic iPSC-derived cells developed an “epi retinal membrane”, which they subsequently removed by operation. Dr. Masayo Takahashi at Riken says “the problem is caused by the transplantation procedure, but not by iPSCs. This will not affect future clinical research that uses iPSCs.”

The laws that govern regenerative medicine in Japan mandates that the deaths and hospitalizations that occur during treatment need to be reported to the government as “serious harmful effects”. This is the first such report involving iPSC clinical research.

The problem occurred to a man in his 70s, who is at the risk of blindness due to “wet age-related macular degeneration”. Last June, he received a transplantation of the solution containing allogeneic iPSC-derived retinal pigment epithelium (RPE) in his left eyes. Last October, the epi retinal membrane and swelling started to develop and the membrane was removed on January 15.

The possibility exists that the solution leaked from the needle hole during the transplantation, and the leaked cells might have formed the membrane. The transplanted cells inside the retina are stable and there has been no decline in his eyesight.

Dr. Takahashi says “although this event qualifies as a serious harmful event, the patient’s condition has not worsened and there has been no rejection of transplanted cells”. Dr. Yasuo Kurimoto, a surgeon who performed the operation, says “the procedure was the problem. We would like to improve the method, in order to make iPSC therapy a common treatment.”

The current clinical trial targets patients with wet age-related macular degeneration and is run by the Kobe City Hospital, Riken, Osaka-University Hospital, and Kyoto-University CiRA (Dr. Shinya Yamanaka). Between last March and October, five patients have received the transplantation.

Original News Credits: https://www.kobe-np.co.jp/news/iryou/201801/0010902012.shtml

Tags: , , , , , , ,

Companies in Stem Cell Therapies

Geron, spinal cord injury

ViaCyte, diabetes, US$10.1 million from CIRM

Blubird Bio, beta-thalassemia, US$9.3 million from CIRM

StemCells, Alzheimer’s US$20 million from CIRM; spinal cord injury US$20 million from CIRM, stocks rise 148% this year.

Osiris, graft-vs.-host disease (GvHD) in children, approved by Canadian regulator Health Canada

Pluristem Therapeutics, aplastic bone marrow, IPO $30 million, shares up 44%.

Cardio3 BioSciences therapy, heart failure, Phase III in Belgium permitted.

TiGenix, cartilage repair in the knee, commercial production; autoimmune, Crohn’s disease Phase III; quarterly revenue up 152% as reported in Oct, 2012.

Advanced Cell Technology, degenerative eye condition, advancing clinical trials in the US and EU.

New Products to be released at next month’s ASCB annual conference in San Francisco: human mRNA-iPS cells, iPSCs with fluorescent markers, neural pregenitors derived from mRNA-iPSCs.

Tags: , , , , , , , , , , , ,

Friday, November 23rd, 2012 iPSCs and other stem cells, Open Forum No Comments