- Email: [email protected]
A preliminary survey for research studies of the national policies on human genetic modification in Mexico
20th Annual ISCT Meeting
User Requirement Specification (URS) were established to ensure that the facility complies with PIC/S and ISO 14644 guidelines. At the same time, the Validation Master Plan (VMP), which consists of a complete set of validation protocol, forms and test reports which will be required for audit, must be completed. Lastly, a proper communication between the contractor and the project manager is crucial to ensure that the facility was built according to the URS. In conclusion, a thorough thinking process, including an understanding of related regulatory requirements, working flow system and working environment, is vital to designing and constructing a GMP facility for CTPs. 161 RELOCATION OF CRYOPRESERVED UMBILICAL CORD BLOOD SAMPLES IN HIGH CAPACITY LIQUID NITROGEN FREEZERS TO A NEW LABORATORY: CRYOCORD, A CORD BLOOD BANKING EXPERIENCE G Ooi1, K Thiagarajah1, C Wong2, VV Vijayan1, K Then1, K Yong1, S Cheong1,3 1 Cryocord Sdn Bhd, Cyberjaya, Selangor, Malaysia, 2Cytopeutics, Cyberjaya, Selangor, Malaysia, 3University Tunku Abdul Rahman, Kajang, Selangor, Malaysia Umbilical cord bloods (UCB) have been used to treat a variety of hematologic disorders and other diseases. To maintain the quality and viability of UCB, processed UCB have to be stored in liquid nitrogen freezers (LNF) at cryogenic temperature until the samples are retrieved, thawed and transplanted. However, when a large number of cryopreserved UCB have to be relocated to a new laboratory at cryogenic temperature, a challenge is presented. In this report, we would like to share our experience on relocating more than ten thousand cryopreserved UCB in twelve LNF into our new laboratory. Procedures including relocating cryopreserved UCB, transporting dry shipper and validating the quality of UCB after relocation were presented in this report. For quality control purpose, two weeks before LNF relocation, donated UCB were processed, cryopreserved and stored at the each LNF. On the day of relocation, half of the donated UCB were retrieved and analyzed for TNC counts, CD34 count and cells viability. These results served as control for later comparison. During UCB relocation, UCB were transferred into high capacity dry shipper before transport to new laboratory. Upon arrival at the new laboratory, LNF were serviced before transferring UCB samples back into original LNF from dry shipper. For quality control, the remaining donated UCB were retrieved and analyzed for the same tests mentioned above. We found that there were no significant differences in all three tests when comparing the UCB samples before and after relocation. In conclusion, all UCB were successfully relocated into new laboratory while maintaining the quality of UCB in terms of TNC counts, CD34 count and cell viability. 162 VALIDATION OF CONDITIONS REQUIRED TO CONTROL THE RATE OF FREEZING OF CELLULAR THERAPY PRODUCTS CRYOPRESERVED BY OVERNIGHT STORAGE AT -80 C C Keever-Taylor1, SM Heidtke1, S Konings1, DA Margolis2 1 Hematology & Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 2Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, United States HPC products collected for later use require cryopreservation to maintain viability. Optimal cell preservation requires both cryoprotectant and a slow cooling rate (<2 degrees/min) from 4C to -45C. Thereafter, products may be cooled more rapidly (5-10 degrees/min) to -80 C or less prior to LN2 storage. We use a programmable LN2 freezer to control the cooling rate and document the desired conditions were met. However, in event of equipment malfunction or for products not intended to restore hematopoiesis we typically store products overnight in a -80 C freezer using a sandwich of Styrofoam blocks to insulate products to achieve a slow cooling rate. Here we report a validation study to optimize this process for the various bag sizes (50, 250 & 500 mL), sources (Miltenyi & Charter Medical) and volumes (20-125 ml) at which we freeze products. We varied the dimensions and thicknesses of Styrofoam blocks and tested polyurethane foam padding for the 50 mL bag. A probe inserted into the bag and connected to
S49
a data logger was used to record temperature every minute. Results confirmed that products cooled too fast without insulation, averaging 5 C/ min to the heat of fusion and >2 C/min thereafter. 0.5” Styrofoam blocks slightly smaller than the cassette were also ineffective. The cooling rate of 250 mL bags containing 60-70 mL and 500 mL bags containing 90-100 mL was consistently <1 C/min when sandwiched in 1” thick blocks that completely covered the cassette. 50 mL bags cooled too rapidly using Styrofoam but could be frozen at the desired rate using 4” thick polyurethane foam cut so as to encase the smaller cassette. We also confirmed that a slow cooling rate was maintained when up to 4 bags, two each sandwiched in two 1” blocks and stacked, were frozen in the same freezer chamber. We conclude that slow cooling of larger bags can be achieved using a -80 C mechanical freezer so long as insulating material is sufficiently thick and covers the cassette, while smaller bags may require more insulation. 163 DEPLETION OF ERYTHROCYTES FROM BONE MARROW GRAFTS BY BUFFY COAT FORMATION USING A COMMERCIALLY AVAILABLE, EFFECTIVELY CLOSED SYSTEM DEVICE AJ Ribickas1, R Smilee1, WE Janssen1,2 1 Cell Therapies Facility, Moffitt Cancer Center, Tampa, Florida, United States, 2Blood and Marrow Transplant, Moffitt Cancer Center, Tampa, Florida, United States Recent clinical data, including a large scale multi-center study, suggest that there will be a continued role for harvested bone marrow as a source of hematopoietic progenitor cells (HPC) for allogeneic transplantation. As there is a significant erythrocyte content in harvested bone marrow, major ABO mismatched transplants generally require some form of erythrocyte depletion from the graft to prevent potential morbidity or mortality from hemolytic reactions at infusion. We have previously reported adaptation of the Haemonetics CellSaverÔ for laboratory use for Ficoll separation of MNC. We have now added simple buffy coat formation for the purpose of erythrocyte depletion to our repertoire of functions for this instrument which is primarily marketed for intra-operative blood salvage. Unprocessed marrow is separated in a bell-shaped bowl that is spinning at 4800rpm. Marrow is pumped into the bowl at 100 mL/min until the bowl is approximately 3/4 full at which point pump speed is reduced to 20 mL/min. A buffy coat layer is observed moving to the top of the packed RBC content of the bowl. As the buffy coat layer reaches the top of the bowl, the waste bag clamps are closed, and the collection bag clamps are opened to effect collection. Once the buffy coat layer has been collected, the pump and bowl centrifuge are stopped. The clamps are then closed on the collection bag, and reopened on the waste bag. The bowl is then emptied of the buffy coat depleted marrow. The red blood cells from the depleted marrow are saved in a satellite bag to be used in further processing of the marrow when additional volume is needed to fill the bowl during a sequence. The sequence above is repeated until the entire volume of marrow has been processed. Depending on the initial volume of marrow to be processed, 1-4 sequences are performed. We have performed this procedure with two bowl sizes, namely 125 mL capacity (n¼7) and 225 mL capacity (n¼5). The extent of RBC depletion, and recovery of both TNC and CD34+ cells is reported in the table.
Bowl Size 125 mL 225 mL
Mean RBC depletion %
Mean TNC recovery %
Mean CD34 recovery %
97.7 79.1
55.3 52.7
65.1 63.3
164 A PRELIMINARY SURVEY FOR RESEARCH STUDIES OF THE NATIONAL POLICIES ON HUMAN GENETIC MODIFICATION IN MEXICO
S50
Poster Abstracts
IO Osadolor1,2, GR Tecpanecatl1 1 Bioethics, Instituto de Ciencias Juridicas de Puebla, A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios., Puebla, Puebla, Mexico
1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico, 3Facultad de ciencias de la Salud. Licenciatura en Medico Cirujano., Universidad Autonoma de Tlaxcala., Tlaxcala, Tlaxcala, Mexico
Genetic modification, often referred to as gene therapy, is a procedure whereby the genetic content (DNA sequence) of a cell, many cells or a whole organism is modified. Most often, non-functional or misfunctioning genes are replaced, manipulated or supplemented with healthy genes. In humans, there are two categories of genetic modification: somatic and germline. Somatic gene therapy consists of introducing a gene or gene segment into specific tissues or organs (excluding germline cells or reproductive cells) in a human subject with the aim of treating or curing an existing condition. Unlike germline genetic modification, somatic gene therapy does not alter the genetic make-up of future generations because the altered gene does not exist in reproductive eggs or sperm. Germline gene therapy, on the other hand, is a more controversial technique because the introduction of a gene into germline cells will result in heritable changes that affect future offspring. Germline gene therapy is not currently scientifically possible in humans (Isasi et al, 2007). In Mexico, humanity is facing a policy deficit at national level concerning social oversight and control of the new technologies of human genetic modification. In the fifteen years since the birth of Dolly the sheep alerted the world to the prospect of human cloning and a new, high-tech eugenics, Mexico has not adopted the policies needed to bring human genetic technology under responsible societal governance. This is a briefed analysis of national policies on genetic modification techniques focused on the legal and ethical standards that have been adopted and the regulatory systems that exist to control and govern genetic modification in Mexico. According to The General Health Law of May 7, 1997: Regulation to the General Health Law on Scientific Health Research (1985), twelve articles were established.
Embryonic stem cell research and therapeutic cloning are permitted, but reproductive cloning is banned (the laws were just amended in 2004). Mexico has a thriving stem cell industry but has not yet implemented formal regulations on stem cell research. Indeed, some Mexican doctors are already using stem cells to treat chronically ill foreigners, including Americans, who suffer from conditions such as cerebral palsy, autism and paralysis. These unregulated therapies have been criticized by some in the international medical community. During the 2003 legislative year, the Chamber of Deputies in Mexico’s Parliament debated legislation about human cloning. In January 2003, the chair of the Chamber’s Health Commission, announced that there would be a propose legislation to ban human cloning in Mexico. One month later, deputies from one of the major parties announced their intention to exclude research cloning from any ban on human cloning. The issue was debated by the Deputies in April 2003, and at year’s end, on 3 December, a bill banning both reproductive and research cloning was approved by the Chamber of Deputies. The President of the Mexican Academy of Sciences and researchers at the National Autonomous University of Mexico (UNAM) responded immediately by vigorously criticizing the Chamber’s action (Macedo and Barba, 2003).
165 A REGULATORY POSITION OF THE ETHICS OF GENETIC ENGINEERING IN MEXICO IO Osadolor1,2, GR Tecpanecatl1 1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico Bioengineering has the potential to transform our lives in many positive ways. Rejection of this new technology on the ground that it is unnatural or inherently immoral is unwarranted and seems to be based on little more than an instinctive adverse reaction. Biotechnology is an extension of already accepted and well-established techniques, such as directed breeding, but with the distinct advantage of producing more predictable and more rapid results. There are risks involved with this new technology, but provided that it is appropriately regulated, its potential benefits outweigh its harms. Legislators and other responsible decision-makers should not implement regulations that unduly restrict implementation of genetic engineering. In particular, existing mechanisms that ensure the safety of testing protocols should be sufficient for somatic genetic therapies for humans. With respect to germline enhancements for plants and animals, we recommend a better coordinated effort of the Mexican regulatory agency to ensure there are no gaps in the regulatory framework. Enhanced organisms should be rigorously evaluated and tested in isolated conditions prior to their release in the wild. Germline alterations for humans should not be prohibited outright, certainly not in advance of their availability. However, given the special risks posed by human germline alterations, each proposed alteration needs to be carefully evaluated, not just with respect to immediate benefits and harms, but also with respect to the effects that the proposed alteration may have on our social structure and the distribution of social goods. Some have compared genetic engineering to a Pandora’s box. If mythological analogies are appropriate, the Center for Inquiry believes a better one would be a comparison to the gift of fire from Prometheus: genetic engineering can provide immense benefits provided it is used prudently and carefully regulated and controlled. 166 THE MEXICAN NATIONAL LEGISLATION CONCERNING HUMAN REPRODUCTIVE AND THERAPEUTIC CLONING IO Osadolor1,2,3, GR Tecpanecatl1, MS Rodriguez3
167 BIOETHICAL ANALYSIS OF THE NEUROREGENERATIVE THERAPIES BASED ON THE USE OF STEM CELLS IN MEXICO IO Osadolor1,2,3, GR Tecpanecatl1, MS Rodriguez3 1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico, 3Facultad de Ciencias de la Salud. Licenciatura en Medico Cirujano, Universidad Autonoma de Tlaxcala, Tlaxcala, Tlaxcala, Mexico One of the main goals of regenerative medicine is to make use of stem cells in the treatment of this type of anomalies. However, the multiple possibilities of obtaining stem cells raise the need for a prior analysis of the suitability use of bioethics. The first step of bioethical analysis of neuroregeneratives therapies requires a proper biological understanding of stem cells. In addition to the classic types of stem cells, cell induction in recent studies have shown that the microclover and potentiality, characteristics of this type of cells, may be induced in any cell through the action of certain molecular signals. The second step of bioethical analysis of neuroregeneratives therapies is the study of the anthropological consequences derived from the donation and transplant of cells. The review of different anthropological models allows to conclude that data provided by the developmental biology are those of greatest relevance at the time of making an assessment of this type. The third and final step of bioethical analysis of neuroregenerativas therapies corresponds to the ethical assessment. Analysis of the two main existing models, the cognitivist and noncognitivist, it is concluded that such valuation from a cognitive model allows a more objective and therefore greater accurate analysis. In the legal field, the analysis of the international and national regulations specifically devoted to this topic highlights the danger posed by the use of a model based on consensus and regulatory minimalism, non-solid anthropological status reference. As a whole, bioethical analysis of neuroregeneratives therapies based on the use of stem cells is concluded that adult stem cells, those derived from the umbilical cord and certain types of induced cells (RiPS) offer more real and safe therapeutic application possibilities. 168 THE EUROPEAN ATMP ‘HOSPITAL EXEMPTION’: A MODEL FOR NORTH AMERICA? B von Tigerstrom College of Law, University of Saskatchewan, Saskatoon, Saskatchewan, Canada The need to create a regulatory framework for regenerative medicine that rigorously protects patient safety, but is flexible enough to allow innovation in response to unmet needs, is the subject of ongoing discussion in many countries. In Europe, the 2007 Advanced Therapy Medicinal Products (ATMP) regulation includes the “hospital exemption,” applying to an ATMP “which is
User Requirement Specification (URS) were established to ensure that the facility complies with PIC/S and ISO 14644 guidelines. At the same time, the Validation Master Plan (VMP), which consists of a complete set of validation protocol, forms and test reports which will be required for audit, must be completed. Lastly, a proper communication between the contractor and the project manager is crucial to ensure that the facility was built according to the URS. In conclusion, a thorough thinking process, including an understanding of related regulatory requirements, working flow system and working environment, is vital to designing and constructing a GMP facility for CTPs. 161 RELOCATION OF CRYOPRESERVED UMBILICAL CORD BLOOD SAMPLES IN HIGH CAPACITY LIQUID NITROGEN FREEZERS TO A NEW LABORATORY: CRYOCORD, A CORD BLOOD BANKING EXPERIENCE G Ooi1, K Thiagarajah1, C Wong2, VV Vijayan1, K Then1, K Yong1, S Cheong1,3 1 Cryocord Sdn Bhd, Cyberjaya, Selangor, Malaysia, 2Cytopeutics, Cyberjaya, Selangor, Malaysia, 3University Tunku Abdul Rahman, Kajang, Selangor, Malaysia Umbilical cord bloods (UCB) have been used to treat a variety of hematologic disorders and other diseases. To maintain the quality and viability of UCB, processed UCB have to be stored in liquid nitrogen freezers (LNF) at cryogenic temperature until the samples are retrieved, thawed and transplanted. However, when a large number of cryopreserved UCB have to be relocated to a new laboratory at cryogenic temperature, a challenge is presented. In this report, we would like to share our experience on relocating more than ten thousand cryopreserved UCB in twelve LNF into our new laboratory. Procedures including relocating cryopreserved UCB, transporting dry shipper and validating the quality of UCB after relocation were presented in this report. For quality control purpose, two weeks before LNF relocation, donated UCB were processed, cryopreserved and stored at the each LNF. On the day of relocation, half of the donated UCB were retrieved and analyzed for TNC counts, CD34 count and cells viability. These results served as control for later comparison. During UCB relocation, UCB were transferred into high capacity dry shipper before transport to new laboratory. Upon arrival at the new laboratory, LNF were serviced before transferring UCB samples back into original LNF from dry shipper. For quality control, the remaining donated UCB were retrieved and analyzed for the same tests mentioned above. We found that there were no significant differences in all three tests when comparing the UCB samples before and after relocation. In conclusion, all UCB were successfully relocated into new laboratory while maintaining the quality of UCB in terms of TNC counts, CD34 count and cell viability. 162 VALIDATION OF CONDITIONS REQUIRED TO CONTROL THE RATE OF FREEZING OF CELLULAR THERAPY PRODUCTS CRYOPRESERVED BY OVERNIGHT STORAGE AT -80 C C Keever-Taylor1, SM Heidtke1, S Konings1, DA Margolis2 1 Hematology & Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 2Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, United States HPC products collected for later use require cryopreservation to maintain viability. Optimal cell preservation requires both cryoprotectant and a slow cooling rate (<2 degrees/min) from 4C to -45C. Thereafter, products may be cooled more rapidly (5-10 degrees/min) to -80 C or less prior to LN2 storage. We use a programmable LN2 freezer to control the cooling rate and document the desired conditions were met. However, in event of equipment malfunction or for products not intended to restore hematopoiesis we typically store products overnight in a -80 C freezer using a sandwich of Styrofoam blocks to insulate products to achieve a slow cooling rate. Here we report a validation study to optimize this process for the various bag sizes (50, 250 & 500 mL), sources (Miltenyi & Charter Medical) and volumes (20-125 ml) at which we freeze products. We varied the dimensions and thicknesses of Styrofoam blocks and tested polyurethane foam padding for the 50 mL bag. A probe inserted into the bag and connected to
S49
a data logger was used to record temperature every minute. Results confirmed that products cooled too fast without insulation, averaging 5 C/ min to the heat of fusion and >2 C/min thereafter. 0.5” Styrofoam blocks slightly smaller than the cassette were also ineffective. The cooling rate of 250 mL bags containing 60-70 mL and 500 mL bags containing 90-100 mL was consistently <1 C/min when sandwiched in 1” thick blocks that completely covered the cassette. 50 mL bags cooled too rapidly using Styrofoam but could be frozen at the desired rate using 4” thick polyurethane foam cut so as to encase the smaller cassette. We also confirmed that a slow cooling rate was maintained when up to 4 bags, two each sandwiched in two 1” blocks and stacked, were frozen in the same freezer chamber. We conclude that slow cooling of larger bags can be achieved using a -80 C mechanical freezer so long as insulating material is sufficiently thick and covers the cassette, while smaller bags may require more insulation. 163 DEPLETION OF ERYTHROCYTES FROM BONE MARROW GRAFTS BY BUFFY COAT FORMATION USING A COMMERCIALLY AVAILABLE, EFFECTIVELY CLOSED SYSTEM DEVICE AJ Ribickas1, R Smilee1, WE Janssen1,2 1 Cell Therapies Facility, Moffitt Cancer Center, Tampa, Florida, United States, 2Blood and Marrow Transplant, Moffitt Cancer Center, Tampa, Florida, United States Recent clinical data, including a large scale multi-center study, suggest that there will be a continued role for harvested bone marrow as a source of hematopoietic progenitor cells (HPC) for allogeneic transplantation. As there is a significant erythrocyte content in harvested bone marrow, major ABO mismatched transplants generally require some form of erythrocyte depletion from the graft to prevent potential morbidity or mortality from hemolytic reactions at infusion. We have previously reported adaptation of the Haemonetics CellSaverÔ for laboratory use for Ficoll separation of MNC. We have now added simple buffy coat formation for the purpose of erythrocyte depletion to our repertoire of functions for this instrument which is primarily marketed for intra-operative blood salvage. Unprocessed marrow is separated in a bell-shaped bowl that is spinning at 4800rpm. Marrow is pumped into the bowl at 100 mL/min until the bowl is approximately 3/4 full at which point pump speed is reduced to 20 mL/min. A buffy coat layer is observed moving to the top of the packed RBC content of the bowl. As the buffy coat layer reaches the top of the bowl, the waste bag clamps are closed, and the collection bag clamps are opened to effect collection. Once the buffy coat layer has been collected, the pump and bowl centrifuge are stopped. The clamps are then closed on the collection bag, and reopened on the waste bag. The bowl is then emptied of the buffy coat depleted marrow. The red blood cells from the depleted marrow are saved in a satellite bag to be used in further processing of the marrow when additional volume is needed to fill the bowl during a sequence. The sequence above is repeated until the entire volume of marrow has been processed. Depending on the initial volume of marrow to be processed, 1-4 sequences are performed. We have performed this procedure with two bowl sizes, namely 125 mL capacity (n¼7) and 225 mL capacity (n¼5). The extent of RBC depletion, and recovery of both TNC and CD34+ cells is reported in the table.
Bowl Size 125 mL 225 mL
Mean RBC depletion %
Mean TNC recovery %
Mean CD34 recovery %
97.7 79.1
55.3 52.7
65.1 63.3
164 A PRELIMINARY SURVEY FOR RESEARCH STUDIES OF THE NATIONAL POLICIES ON HUMAN GENETIC MODIFICATION IN MEXICO
S50
Poster Abstracts
IO Osadolor1,2, GR Tecpanecatl1 1 Bioethics, Instituto de Ciencias Juridicas de Puebla, A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios., Puebla, Puebla, Mexico
1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico, 3Facultad de ciencias de la Salud. Licenciatura en Medico Cirujano., Universidad Autonoma de Tlaxcala., Tlaxcala, Tlaxcala, Mexico
Genetic modification, often referred to as gene therapy, is a procedure whereby the genetic content (DNA sequence) of a cell, many cells or a whole organism is modified. Most often, non-functional or misfunctioning genes are replaced, manipulated or supplemented with healthy genes. In humans, there are two categories of genetic modification: somatic and germline. Somatic gene therapy consists of introducing a gene or gene segment into specific tissues or organs (excluding germline cells or reproductive cells) in a human subject with the aim of treating or curing an existing condition. Unlike germline genetic modification, somatic gene therapy does not alter the genetic make-up of future generations because the altered gene does not exist in reproductive eggs or sperm. Germline gene therapy, on the other hand, is a more controversial technique because the introduction of a gene into germline cells will result in heritable changes that affect future offspring. Germline gene therapy is not currently scientifically possible in humans (Isasi et al, 2007). In Mexico, humanity is facing a policy deficit at national level concerning social oversight and control of the new technologies of human genetic modification. In the fifteen years since the birth of Dolly the sheep alerted the world to the prospect of human cloning and a new, high-tech eugenics, Mexico has not adopted the policies needed to bring human genetic technology under responsible societal governance. This is a briefed analysis of national policies on genetic modification techniques focused on the legal and ethical standards that have been adopted and the regulatory systems that exist to control and govern genetic modification in Mexico. According to The General Health Law of May 7, 1997: Regulation to the General Health Law on Scientific Health Research (1985), twelve articles were established.
Embryonic stem cell research and therapeutic cloning are permitted, but reproductive cloning is banned (the laws were just amended in 2004). Mexico has a thriving stem cell industry but has not yet implemented formal regulations on stem cell research. Indeed, some Mexican doctors are already using stem cells to treat chronically ill foreigners, including Americans, who suffer from conditions such as cerebral palsy, autism and paralysis. These unregulated therapies have been criticized by some in the international medical community. During the 2003 legislative year, the Chamber of Deputies in Mexico’s Parliament debated legislation about human cloning. In January 2003, the chair of the Chamber’s Health Commission, announced that there would be a propose legislation to ban human cloning in Mexico. One month later, deputies from one of the major parties announced their intention to exclude research cloning from any ban on human cloning. The issue was debated by the Deputies in April 2003, and at year’s end, on 3 December, a bill banning both reproductive and research cloning was approved by the Chamber of Deputies. The President of the Mexican Academy of Sciences and researchers at the National Autonomous University of Mexico (UNAM) responded immediately by vigorously criticizing the Chamber’s action (Macedo and Barba, 2003).
165 A REGULATORY POSITION OF THE ETHICS OF GENETIC ENGINEERING IN MEXICO IO Osadolor1,2, GR Tecpanecatl1 1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico Bioengineering has the potential to transform our lives in many positive ways. Rejection of this new technology on the ground that it is unnatural or inherently immoral is unwarranted and seems to be based on little more than an instinctive adverse reaction. Biotechnology is an extension of already accepted and well-established techniques, such as directed breeding, but with the distinct advantage of producing more predictable and more rapid results. There are risks involved with this new technology, but provided that it is appropriately regulated, its potential benefits outweigh its harms. Legislators and other responsible decision-makers should not implement regulations that unduly restrict implementation of genetic engineering. In particular, existing mechanisms that ensure the safety of testing protocols should be sufficient for somatic genetic therapies for humans. With respect to germline enhancements for plants and animals, we recommend a better coordinated effort of the Mexican regulatory agency to ensure there are no gaps in the regulatory framework. Enhanced organisms should be rigorously evaluated and tested in isolated conditions prior to their release in the wild. Germline alterations for humans should not be prohibited outright, certainly not in advance of their availability. However, given the special risks posed by human germline alterations, each proposed alteration needs to be carefully evaluated, not just with respect to immediate benefits and harms, but also with respect to the effects that the proposed alteration may have on our social structure and the distribution of social goods. Some have compared genetic engineering to a Pandora’s box. If mythological analogies are appropriate, the Center for Inquiry believes a better one would be a comparison to the gift of fire from Prometheus: genetic engineering can provide immense benefits provided it is used prudently and carefully regulated and controlled. 166 THE MEXICAN NATIONAL LEGISLATION CONCERNING HUMAN REPRODUCTIVE AND THERAPEUTIC CLONING IO Osadolor1,2,3, GR Tecpanecatl1, MS Rodriguez3
167 BIOETHICAL ANALYSIS OF THE NEUROREGENERATIVE THERAPIES BASED ON THE USE OF STEM CELLS IN MEXICO IO Osadolor1,2,3, GR Tecpanecatl1, MS Rodriguez3 1 Bioethics, Instituto de Ciencias Juridicas A.C., Puebla, Puebla, Mexico, 2Law and Bioethics, Instituto de Estudios Universitarios, Puebla, Puebla, Mexico, 3Facultad de Ciencias de la Salud. Licenciatura en Medico Cirujano, Universidad Autonoma de Tlaxcala, Tlaxcala, Tlaxcala, Mexico One of the main goals of regenerative medicine is to make use of stem cells in the treatment of this type of anomalies. However, the multiple possibilities of obtaining stem cells raise the need for a prior analysis of the suitability use of bioethics. The first step of bioethical analysis of neuroregeneratives therapies requires a proper biological understanding of stem cells. In addition to the classic types of stem cells, cell induction in recent studies have shown that the microclover and potentiality, characteristics of this type of cells, may be induced in any cell through the action of certain molecular signals. The second step of bioethical analysis of neuroregeneratives therapies is the study of the anthropological consequences derived from the donation and transplant of cells. The review of different anthropological models allows to conclude that data provided by the developmental biology are those of greatest relevance at the time of making an assessment of this type. The third and final step of bioethical analysis of neuroregenerativas therapies corresponds to the ethical assessment. Analysis of the two main existing models, the cognitivist and noncognitivist, it is concluded that such valuation from a cognitive model allows a more objective and therefore greater accurate analysis. In the legal field, the analysis of the international and national regulations specifically devoted to this topic highlights the danger posed by the use of a model based on consensus and regulatory minimalism, non-solid anthropological status reference. As a whole, bioethical analysis of neuroregeneratives therapies based on the use of stem cells is concluded that adult stem cells, those derived from the umbilical cord and certain types of induced cells (RiPS) offer more real and safe therapeutic application possibilities. 168 THE EUROPEAN ATMP ‘HOSPITAL EXEMPTION’: A MODEL FOR NORTH AMERICA? B von Tigerstrom College of Law, University of Saskatchewan, Saskatoon, Saskatchewan, Canada The need to create a regulatory framework for regenerative medicine that rigorously protects patient safety, but is flexible enough to allow innovation in response to unmet needs, is the subject of ongoing discussion in many countries. In Europe, the 2007 Advanced Therapy Medicinal Products (ATMP) regulation includes the “hospital exemption,” applying to an ATMP “which is