Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantation
Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in TransplantationsSummary of Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations
Position Statement of the Japan Society for Hematopoietic Cell Transplantation regarding the use of Biosimilar Granulocyte-Colony Stimulating Factors for the mobilization of hematopoietic stem cells in healthy donors
The Japan Society for Hematopoietic Cell Transplantation (JSHCT)
Recombinant granulocyte colony-stimulating factor (G-CSF) has been widely used for patients with granulocytopenia since its launch in 1990s by three pharmaceutical companies. Its indication for the mobilization of hematopoietic stem cells in healthy donors was subsequently approved in April, 2000. JSHCT has been making effort to collect short and long-term adverse events associated with the use of G-CSF in healthy donors. The short and long-term safety data of related donors were collected from April 2000 to March 2010, and was presented in September 2010. The results showed that the constant occurrence of adverse events for which causal relationship with G-CSF could not be denied, but some of the events were predictable and could be avoided. It has also become clear that the incidence of hematologic malignancy in peripheral blood stem cell donors after the use of G-CSF was similar to that observed in bone marrow donors (the data were presented at 31st EBMT, 47th ASH, 33rd EBMT and 52nd ASH meetings). With these findings in related donors from those prospective investigational studies, G-CSF was approved for the use in unrelated donors, and unrelated allogeneic peripheral blood stem cell transplantation (PBSCT) became possible in Japan in September 2010. At the moment, three biosimilar G-CSF have been applying for license (one of them has already been approved in November 2012) and their indications include the use for the mobilization of stem cells in healthy donors even though clinical trials have not been conducted in healthy donors. JSHCT concludes it preferable that biosimilar G-CSFs need to adopt the same steps which original G-CSF adopted, and JSHCT makes our members thoroughly aware of following two things;
- Regarding the mobilization of allo-PBSCT in healthy donors, it should be started with related donors first and register them through the JSHCT pre-registry and follow-up system (Upon registry, we need to consider to establish the system which identifies the name of products used).
- The use for unrelated volunteer donors should be suspended until short and long-term safety of biosimilar G-CSF is confirmed.
Securing safety of HSCT donors, especially unrelated donors, is one of the main issues of "Act on Promoting Appropriate Offering of Hematopoietic Stem Cells for Transplantation." Therefore, JSHCT wishes the companies producing biosimilar G-CSF understand the meaning of two statements mentioned above. Our position statement is based on our research to secure safety for donors and at the same time matches international view. Therefore, our statement may be reconsidered on each occasion when particular changes in the international view occur in the future.
The second statement from Japan Society for Hematopoietic Cell Transplantation (JSHCT) on recent earthquake disaster and subsequent nuclear power plant accident in Japan.
May 31, 2011
Japan Society for Hematopoietic Cell Transplantation (JSHCT)
The JSHCT express our deepest condolence and sympathy again for all the losses and peoples still enduring this very difficult time, and we also show our sincere deference to those who are working so hard to rescue and restore the affected areas. The JSHCT has been taking necessary actions to support the patients or victims in disabled areas according to the plans listed on our previous statement. Since that time, the situation of disabled area including Fukushima nuclear power plant has kept changing, but it remains to be unsettled. Taking those changes into considerations, the JSHCT hereby summarize our views of settlement and supports for those who are still suffering from the sequela of the recent disaster.
- The JSHCT will continue to work together closely with donor registries and related organizations in order to ensure that the patients in affected area, who in needs for hematopoietic stem cell transplantation as standard of care, will receive the procedure without any delay.
- The JSHCT requests the authorities responsible for the operation of Fukushima nuclear power plant to take necessary steps to secure the safety of nuclear workers. Those include medical check-up with the tests for estimating the dose of their radiation exposure according to the law and guidelines in order to avoid both acute and late radiation injury. In addition, the JSHCT again requests the authorities to disclose detailed data and information on the workers working at the site and to establish the work project and working hours to secure protect them from high-dose radiation exposure accordingly.
- The radiation level of inside of Fukushima nuclear power plant remains high, and it is expected to take a long time to recover the disabled nuclear plant. Under those circumstances, together with the fact that the precise and detailed information on the radiation dose and the health status of nuclear workers have not been disclosed properly on timely fashion, the JSHCT considered that the risk of accidental radiation exposure will accumulate for the nuclear workers. Therefore, the JSHCT continue to collaborate with transplant centers where the peripheral blood hematopoietic stem cell (PBSC) harvest and collection is available. Currently, 107 transplant teams are standing by to collect and store their own stem cells for nuclear workers who are at a risk of accidental high-dose radiation exposure through their works at the sites of accident.
- However, autologous PBSC transplantation is not a perfect strategy to treat radiation victims as the procedure rescues only the hematopoietic capacity but no other tissues. The JSHCT concerns that having a safety net of stored cells could encourage unnecessarily dangerous behavior among the workers, increasing the risk of health problems, thus we would like to reemphasize that all the measures for protecting the nuclear workers from high-dose radiation should be a matter of highest priority.
- The JSHCT will continue to work together with ninety five transplant teams and donor/stem cell banks, and is standing by in order to perform hematopoietic stem cell transplantation by using all kinds of stem cell sources including cryopreserved autologous stem cells in timely fashion if unfortunately the accidental high-dose radiation exposure occurs.
- The JSHCT considers it essential to share our experience together with the above mentioned detailed data regarding the nuclear workers with both domestic as well as oversea donor registries, organizations, and academic societies in order to set up or refine the protocols of multidisciplinary team approaches in order to prepare for nuclear power plant accident in future.
- The systems and networks supporting hematopoietic stem cell transplantation have almost completely restored and become capable to deal with massive radiation victims. The JSHCT now considers the situation where our medical resources are overwhelmed for handling massive accidental radiation victims becomes unlikely. The JSHCT would like to express again our sincere appreciation to many oversea academic organizations and stem cell banks for kindly offering their resources at the beginning of the disaster.
The statement from Japan Society for Hematopoietic Cell Transplantation (JSHCT) on recent earthquake disaster and subsequent nuclear power plant accident in Japan.
March 29, 2011
Japan Society for Hematopoietic Cell Transplantation (JSHCT)
The Japan Society for Hematopoietic Cell Transplantation (JSHCT) would like to express our deepest sympathy for all the losses and peoples still enduring this very difficult time. The JSHCT will work together by all means to overcome this devastation and hereby declare that we will offer the following supports.
- As of March 24, 2011, one hundred and sixty eight transplant teams participating in the JSHCT are ready to accept patients for whom the allogeneic stem cell transplantations had been scheduled but were postponed or cancelled because of the disaster (173 teams are also available for those who are in need of autologous stem cell transplantation).
- In addition, ninety one transplant teams are standing by to treat victims of radiation exposure from the nuclear power plant accident.
- Also, 107 transplant teams are standing by to collect and store their own hematopoietic stem cells from the peripheral blood for workers who are striving to restrain the radiation. However, this procedure must not be considered as securing the work in high radiation exposure and JSHCT re-emphasize the protecting them from high radiation exposure remains essential.
- The above mentioned supports from JSHCT are not applied for the general public at this moment.
The JSHCT requests the authorities related to the operation of nuclear power plant in Fukushima to disclose more detailed data and information that helps us to plan and prepare more precise setup to treat possible nuclear accident victims.
Finally, the JSHCT would like to express our sincere appreciation for generous offers from CIBMTR/ASBMT, EBMT, NMDP, WBMT, and many other organizations of the world in case of our medical resources are overwhelmed.