Technocracy
Member
Question: Why do you feel that stem cells derived from the placenta are superior to any other type of stem cells currently being used in treatments?
Answer: There are several reasons why I believe stem cell derived from the placenta are potentially superior cells:
? Placental-derived stem cells (we call our cells at Pluristem, Inc. PLX cells) are adult stem cells. Therefore these cells are not embryonic in origin and have no ethical controversies associated with them. I want to emphasize that our PLX cells do not come from cord blood, which is milked from the placenta. PLX cells come from the body of the placental organ itself.
? Placental-derived stem cells come from an organ that has, until relatively recently, been considered medical waste. For the vast majority of the population, the placenta (after-birth) is destroyed after birth. Therefore, in addition to a plentiful supply of inexpensive raw material to grow cells, PLX cells are obtained without anyone ever being hurt or even touched to obtain the raw material. This is in contrast, for example, to stem cells obtained from organs such as bone marrow or fat where invasive procedures are needed to get the raw material to grow the stem cells.
? Independent peer-reviewed journal articles have suggested that cells derived from the more ?fetal? organs, such as the amnion, Wharton?s Jelly and the placenta will prove in the future to be the best cells to be used therapeutically. This is in contrast to cells obtained from ?older organs? such as bone marrow or fat.
Question: Is it possible to use stem cells from the placenta to treat neurodevelopmental disorders like Autism? Would these types of cells produce angiogenesis in the brain too, like the effect on the limbs?
Answer: I believe it is reasonable to assume that PLX cells can promote angiogenesis in any organ if the cells are deposited in the right amount, in the right location and at the right time. Pluristem has animal data that PLX cells can potentially be useful in stroke, MS and inflammatory bowel disease (IBD) and I suspect the mechanism of action for the therapeutics effects of the cells is angiogenesis. Not sure about autism because I am not sure of the etiology of the disease.
Question: How much research is currently being conducted with placental cells?
Answer: In addition to university-based facilities in the US and abroad, there are several companies investigating placental-derived stem cells. In addition to Pluristem, Celgene and JNJ Ethicon?s division are researching these cells. Pluristem?s PLX cells are differentiated from these other companies in how we expand or grow the cells. We expand the cells in a patented, three-dimensional (3D) bioenvironment that is an easily scalable manufacturing process that allows large numbers of cells to be grown inexpensively.
Question: Please explain the differences between placental, umbilical, marrow and embryonic stem cells.
Answer: Placental, umbilical and marrow stem cells are adult stem cells. They are, therefore non-controversial. To obtain embryonic stem cells (ESC), an embryo is destroyed with a segment of our population believing that is the same a destroying a human life.
Umbilical cells usually suggests cells that are contained in cord blood, which is milked from the umbilical cord. However, there has been some recent research suggesting stem cells from the wall of the umbilical cord may have value.
Marrow cells come from the bone marrow. To obtain bone marrow, a surgical procedure is necessary with its associated risks.
Placental cells come from the placenta (see answer to question #1 above).
Question: Greetings from the Philippines. I am a COPD sufferer, 51 years old, diagnosed in 2006. Does your stem cell treatment treat this condition and how successful would you say this placenta method is in treating COPD? If you are not currently treating COPD, is this in yourfuture plans?
Answer: Hello Philippines. My personal opinion is that PLX cells will not be useful for COPD as I consider this a more structural disease than inflammatory process and our cell?s mechanism of action is believed primary anti-inflammatory. You probably know that Osiris recently reported unfavorable results in using their bone marrow derived cells in COPD patients.
Question: There have been numerous recent claims worldwide of good results for cardiac cases. These have been cells originating from centrifuged autologous marrow, expanded autologous marrow components, autologous peripheral blood, fewer good results from non-autologous cord and placenta cells, and some people claiming to get good results from skin and fat cells. Most of the published studies involve treatment to prevent dead cardiac tissue following heart attacks. I have little cardiac tissue loss, after 2 or 3 minor heart attacks, but have 3 of 4 failed bypass grafts, and 20+ stents have failed. With circulation starting to weaken to my legs, and currently on high doses of beta blockers and other maximal therapy, I desire angiogenesis and circulation more than cardiac tissue regeneration.
One facility in the USA will treat now with expanded marrow cells as an IND, and they have a focus on PAD and angiogenesis like you do.
I have had 4 autologous stem cell treatments outside the USA from marrow and peripheral blood via i/v and i/m to my legs, and having my health decline, the questions for me now are what type of cells to use, and where should the cells be administered. I do not wish to leave the USA again for treatment.
What would be the pros and cons of waiting until your technology is fully approved for me?
Answer: It sounds like your primary problem is more related to symptoms and signs in your legs than your heart. If you meet our eligibility criteria, you may be a candidate for our PLX trial. To obtain additional information and contact numbers, please go to the following web site for contact info, etc.:
http://clinicaltrials.gov/ct2/show/NCT00951210?term=pluristem&rank=2
The pro of entering our trial is that you will be treated with allogeneic cells whereas you have apparently been previously treated with autologous cells that apparently did not do as much as you wanted. Also, the trial is an ?open-label? trial so everyone receives the cell therapy. No controls in this Phase I safety study.
The con of entering the trial is that the cells may do nothing to help you. The efficacy parameters in our study are measured for 3 mos. and assume, therefore, that if you are not better in 3 mos. you probably will not get better.
Question: Greetings and Welcome to the Forum!
Several of us on the forum have had multiple stem cell treatments, with cells derived from one source or another. Quite a few of us have also tried multiple cell sources from different clinics here and there, across the globe! Quite a few forum members have seen benefit from stem cell therapy (of one source or another).
We have dealt with people who care, and with those who would simply separate us from our bank balances. Many of us are low on funds but would like to live long enough to be treated by a breakthrough discovery or product. I would certainly like to receive a bona-fide stem cell treatment of some sort while I am alive.
Where do you see the current "state of the art" to be in terms of stem cell treatment being true beneficial therapy?
Answer: Difficult question because I think stem cells for some indications are closer to reality that others. I kind of globally think this:
Embryonic stem cells ? Exceeding long time to a commercial product, if ever.
Adult stem cells ? Much shorter time to commercialization.
For local indications ? things like limb ischemia, orthopedic injuries etc. where the cells are injected locally? probably quickest time to commercialization.
For regional indications- things like the prevention of organ rejection where cells are injected regionally (like an artery to an organ or the organ itself) ? intermediate time to commercialization.
For systemic indications ? things like stroke, MS, IBD etc. where the cells are injected intravenously ? longest time to commercialization
Hope this helps.
Question: How many months or years do you see us being away from key discoveries in this arena?
Answer: Key scientific discoveries happening almost daily. However practical use of these discoveries are years away. Pluristem hopes to have their first product on the market in 2014 or so.
Question: Can you offer any insight into sc treatment for sensorineural hearing loss? Nerve deafness? Do you have any knowledge about anyone treating it or have you heard of any successes? Do you have any suggestions?
Unfortunately I have heard nothing on the use of either ESC or ASC for use in sensorineural hearing loss. However, I tend to focus on placental-derived stem cells.
I would think that the basic question is how much of your sensorineural hearing loss is caused by an inflammatory component and how much is structural damage. The reason I say this is I think adult stem cell?s primary mechanism of action is anti-inflammatory while the embryonic stem cell?s mechanism of action is cell differentiation.
Question: How did you personally become involved in the stem cell "industry"? I believe doctors and researchers who are involved are visionary and true Pioneers. Thank you.
Answer: Although I am a Pharmacist and a physician, I am also a businessman. My decision to pursue the ?stem cell industry? came from believing that stem cells as a business will be lucrative and a desire to help my fellow man.
Question: Is treatment available from your company in Israel or is all of your work currently focused on clinical trials and research? If treatment is available, what diseases are you treating?
Answer: Pluristem has no products that are currently commercially available. We are in clinical trials in Europe and the USA for limb ischemia, the end stage of peripheral vascular disease. Our web site is pluristem.com
About Dr. Prather
My name is William R. Prather RPh, MD and I am the Senior Vice President of Corporate Development for Pluristem Therapeutics Inc. Pluristem is an American, public (NASDAQ: PSTI) bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching. Pluristem then grows these cells in a proprietary three dimensional environment with the resultant cells termed PLacental eXpanded (PLX) cells. Pluristem believes that the PLX cells? mechanism of action may be related to the secretion of cytokines and/or other potent immune modulators.
Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), received clearance from the Food and Drug Administration (FDA) and the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, to begin Phase I clinical trials in Europe and the United States.
The European trial has been posted on the clinicaltrial.gov website with the specific address being: http://clinicaltrials.gov/ct2/show/NCT00919958?term=pluristem&rank=1. The US trial posting is pending but the purpose of the study, eligibility and inclusion/exclusion criteria are identical to the European trial. Twelve patients will be enrolled in this safety dose-escalation trial at two sites in the US. The clinical sites will be located at Duke University Medical Center in Durham, North Carolina and Princeton Baptist Medical Center in Birmingham, Alabama.
A little about me. I am a registered pharmacist and a physician. I practiced internal medicine in Missouri and Colorado before completing a Geriatric fellowship at Harvard University. I then left the active practice of medicine and entered the business world and was a biotechnology analyst for several healthcare investment banks. I then entered industry and was a co-founder of a company called Panacos Therapeutics, Inc. and remained with them until they went public. Since that time and for approximately 3 ? years I have been a member of the management team of Pluristem.
Answer: There are several reasons why I believe stem cell derived from the placenta are potentially superior cells:
? Placental-derived stem cells (we call our cells at Pluristem, Inc. PLX cells) are adult stem cells. Therefore these cells are not embryonic in origin and have no ethical controversies associated with them. I want to emphasize that our PLX cells do not come from cord blood, which is milked from the placenta. PLX cells come from the body of the placental organ itself.
? Placental-derived stem cells come from an organ that has, until relatively recently, been considered medical waste. For the vast majority of the population, the placenta (after-birth) is destroyed after birth. Therefore, in addition to a plentiful supply of inexpensive raw material to grow cells, PLX cells are obtained without anyone ever being hurt or even touched to obtain the raw material. This is in contrast, for example, to stem cells obtained from organs such as bone marrow or fat where invasive procedures are needed to get the raw material to grow the stem cells.
? Independent peer-reviewed journal articles have suggested that cells derived from the more ?fetal? organs, such as the amnion, Wharton?s Jelly and the placenta will prove in the future to be the best cells to be used therapeutically. This is in contrast to cells obtained from ?older organs? such as bone marrow or fat.
Question: Is it possible to use stem cells from the placenta to treat neurodevelopmental disorders like Autism? Would these types of cells produce angiogenesis in the brain too, like the effect on the limbs?
Answer: I believe it is reasonable to assume that PLX cells can promote angiogenesis in any organ if the cells are deposited in the right amount, in the right location and at the right time. Pluristem has animal data that PLX cells can potentially be useful in stroke, MS and inflammatory bowel disease (IBD) and I suspect the mechanism of action for the therapeutics effects of the cells is angiogenesis. Not sure about autism because I am not sure of the etiology of the disease.
Question: How much research is currently being conducted with placental cells?
Answer: In addition to university-based facilities in the US and abroad, there are several companies investigating placental-derived stem cells. In addition to Pluristem, Celgene and JNJ Ethicon?s division are researching these cells. Pluristem?s PLX cells are differentiated from these other companies in how we expand or grow the cells. We expand the cells in a patented, three-dimensional (3D) bioenvironment that is an easily scalable manufacturing process that allows large numbers of cells to be grown inexpensively.
Question: Please explain the differences between placental, umbilical, marrow and embryonic stem cells.
Answer: Placental, umbilical and marrow stem cells are adult stem cells. They are, therefore non-controversial. To obtain embryonic stem cells (ESC), an embryo is destroyed with a segment of our population believing that is the same a destroying a human life.
Umbilical cells usually suggests cells that are contained in cord blood, which is milked from the umbilical cord. However, there has been some recent research suggesting stem cells from the wall of the umbilical cord may have value.
Marrow cells come from the bone marrow. To obtain bone marrow, a surgical procedure is necessary with its associated risks.
Placental cells come from the placenta (see answer to question #1 above).
Question: Greetings from the Philippines. I am a COPD sufferer, 51 years old, diagnosed in 2006. Does your stem cell treatment treat this condition and how successful would you say this placenta method is in treating COPD? If you are not currently treating COPD, is this in yourfuture plans?
Answer: Hello Philippines. My personal opinion is that PLX cells will not be useful for COPD as I consider this a more structural disease than inflammatory process and our cell?s mechanism of action is believed primary anti-inflammatory. You probably know that Osiris recently reported unfavorable results in using their bone marrow derived cells in COPD patients.
Question: There have been numerous recent claims worldwide of good results for cardiac cases. These have been cells originating from centrifuged autologous marrow, expanded autologous marrow components, autologous peripheral blood, fewer good results from non-autologous cord and placenta cells, and some people claiming to get good results from skin and fat cells. Most of the published studies involve treatment to prevent dead cardiac tissue following heart attacks. I have little cardiac tissue loss, after 2 or 3 minor heart attacks, but have 3 of 4 failed bypass grafts, and 20+ stents have failed. With circulation starting to weaken to my legs, and currently on high doses of beta blockers and other maximal therapy, I desire angiogenesis and circulation more than cardiac tissue regeneration.
One facility in the USA will treat now with expanded marrow cells as an IND, and they have a focus on PAD and angiogenesis like you do.
I have had 4 autologous stem cell treatments outside the USA from marrow and peripheral blood via i/v and i/m to my legs, and having my health decline, the questions for me now are what type of cells to use, and where should the cells be administered. I do not wish to leave the USA again for treatment.
What would be the pros and cons of waiting until your technology is fully approved for me?
Answer: It sounds like your primary problem is more related to symptoms and signs in your legs than your heart. If you meet our eligibility criteria, you may be a candidate for our PLX trial. To obtain additional information and contact numbers, please go to the following web site for contact info, etc.:
http://clinicaltrials.gov/ct2/show/NCT00951210?term=pluristem&rank=2
The pro of entering our trial is that you will be treated with allogeneic cells whereas you have apparently been previously treated with autologous cells that apparently did not do as much as you wanted. Also, the trial is an ?open-label? trial so everyone receives the cell therapy. No controls in this Phase I safety study.
The con of entering the trial is that the cells may do nothing to help you. The efficacy parameters in our study are measured for 3 mos. and assume, therefore, that if you are not better in 3 mos. you probably will not get better.
Question: Greetings and Welcome to the Forum!
Several of us on the forum have had multiple stem cell treatments, with cells derived from one source or another. Quite a few of us have also tried multiple cell sources from different clinics here and there, across the globe! Quite a few forum members have seen benefit from stem cell therapy (of one source or another).
We have dealt with people who care, and with those who would simply separate us from our bank balances. Many of us are low on funds but would like to live long enough to be treated by a breakthrough discovery or product. I would certainly like to receive a bona-fide stem cell treatment of some sort while I am alive.
Where do you see the current "state of the art" to be in terms of stem cell treatment being true beneficial therapy?
Answer: Difficult question because I think stem cells for some indications are closer to reality that others. I kind of globally think this:
Embryonic stem cells ? Exceeding long time to a commercial product, if ever.
Adult stem cells ? Much shorter time to commercialization.
For local indications ? things like limb ischemia, orthopedic injuries etc. where the cells are injected locally? probably quickest time to commercialization.
For regional indications- things like the prevention of organ rejection where cells are injected regionally (like an artery to an organ or the organ itself) ? intermediate time to commercialization.
For systemic indications ? things like stroke, MS, IBD etc. where the cells are injected intravenously ? longest time to commercialization
Hope this helps.
Question: How many months or years do you see us being away from key discoveries in this arena?
Answer: Key scientific discoveries happening almost daily. However practical use of these discoveries are years away. Pluristem hopes to have their first product on the market in 2014 or so.
Question: Can you offer any insight into sc treatment for sensorineural hearing loss? Nerve deafness? Do you have any knowledge about anyone treating it or have you heard of any successes? Do you have any suggestions?
Unfortunately I have heard nothing on the use of either ESC or ASC for use in sensorineural hearing loss. However, I tend to focus on placental-derived stem cells.
I would think that the basic question is how much of your sensorineural hearing loss is caused by an inflammatory component and how much is structural damage. The reason I say this is I think adult stem cell?s primary mechanism of action is anti-inflammatory while the embryonic stem cell?s mechanism of action is cell differentiation.
Question: How did you personally become involved in the stem cell "industry"? I believe doctors and researchers who are involved are visionary and true Pioneers. Thank you.
Answer: Although I am a Pharmacist and a physician, I am also a businessman. My decision to pursue the ?stem cell industry? came from believing that stem cells as a business will be lucrative and a desire to help my fellow man.
Question: Is treatment available from your company in Israel or is all of your work currently focused on clinical trials and research? If treatment is available, what diseases are you treating?
Answer: Pluristem has no products that are currently commercially available. We are in clinical trials in Europe and the USA for limb ischemia, the end stage of peripheral vascular disease. Our web site is pluristem.com
About Dr. Prather
My name is William R. Prather RPh, MD and I am the Senior Vice President of Corporate Development for Pluristem Therapeutics Inc. Pluristem is an American, public (NASDAQ: PSTI) bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source. The (PLacental eXpanded) cell products are stored off-the-shelf, ready-to-use, and require no histocompatibility matching. Pluristem then grows these cells in a proprietary three dimensional environment with the resultant cells termed PLacental eXpanded (PLX) cells. Pluristem believes that the PLX cells? mechanism of action may be related to the secretion of cytokines and/or other potent immune modulators.
Pluristem's first product, PLX-PAD (for the treatment of Peripheral Artery Disease), received clearance from the Food and Drug Administration (FDA) and the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, to begin Phase I clinical trials in Europe and the United States.
The European trial has been posted on the clinicaltrial.gov website with the specific address being: http://clinicaltrials.gov/ct2/show/NCT00919958?term=pluristem&rank=1. The US trial posting is pending but the purpose of the study, eligibility and inclusion/exclusion criteria are identical to the European trial. Twelve patients will be enrolled in this safety dose-escalation trial at two sites in the US. The clinical sites will be located at Duke University Medical Center in Durham, North Carolina and Princeton Baptist Medical Center in Birmingham, Alabama.
A little about me. I am a registered pharmacist and a physician. I practiced internal medicine in Missouri and Colorado before completing a Geriatric fellowship at Harvard University. I then left the active practice of medicine and entered the business world and was a biotechnology analyst for several healthcare investment banks. I then entered industry and was a co-founder of a company called Panacos Therapeutics, Inc. and remained with them until they went public. Since that time and for approximately 3 ? years I have been a member of the management team of Pluristem.