About MedistemThomas Ichim, PhD is CEO of Medistem, Inc. He has served a variety of instrumental roles for companies in the are of biologics. He obtained numerous regulatory approvals for companies such as MarrowTech Pharma, and worked as a Program Director for the global CRO bioRASI, under which he led efforts to develop, clinically assess, and approve various stem cell and cellular therapies. Thomas has also founded two companies, ToleroTech, Inc. and MedVax Pharma Corp., which are developing proprietary technologies in the areas of RNA interference and cancer vaccines, respectively. He is an accomplished scientist with 15 scientific papers published in areas ranging from immunological tolerance to cancer therapy, to autoimmunity. He has numerous patents filed and issued covering diverse topics. You can find many video presentations done by Mr. Ichim by doing an internet search. You can also follow him on Twitter.
Q: Would your company's (Medistem) endometrial stem cells (ERC) be good for disorders of the brain such as autism or cerebral palsy?
A: First before I begin, let me state that because Medistem is a public company with shares on the pink sheets (MEDS.PK), comments I make here are strictly my own and not necessarily representative of Medistem’s opinion. Additionally, comments here are not medical advice and may contain “forward-looking statements”.
Endometrial regenerative cells (ERC) are highly angiogenic and vasculogenic, meaning that they are useful in the production of new blood vessels in tissues that lack oxygen. In stroke, cells identical to ERC have been demonstrated to induce a potent therapeutic response (Borlongan et al. Menstrual blood cells display stem cell-like phenotypic markers and exert neuroprotection following transplantation in experimental stroke. Stem Cells Dev. 2010 Apr;19(4):439-52), since cerebral palsy has some similarities at a molecular and cellular level to stroke, there may be some rationale for their use. Other angiogenic stem cells, such as adipose stem cells, have been demonstrated to exert therapeutic responses in animal models of cerebral palsy (Wei et al. IFATS collection: The conditioned media of adipose stromal cells protect against hypoxia-ischemia-induced brain damage in neonatal rats. Stem Cells. 2009 Feb;27(2):478-88). Whether ERC will be useful clinically in these conditions requires clinical trials. Currently the company is highly focused on critical limb ischemia and congestive heart failure, for which we have FDA approval and Russian Regulatory approval for clinical trials.
Q: If stem cell therapy is attempted to rebuild emphysematous lungs, does that mean the inflation that has taken place is reversed as new alveoli and blood channels are (hopefully) created, so that in essence the lungs "shrink" back to a normal size? Or do they become more efficient, retrofitted as it were, with new functional tissue--but with the inflation staying the same? What do animal studies tell us?
A: It depends on the animal system used. There are some examples in which new alveoli have been demonstrated with stem cell administration. However the majority of experiments use the stem cells at the same time as the injury and show inhibition of progression of injury. In a recent paper the molecular basis of alveoli regeneration was demonstrated (Kumar et al. Distal Airway Stem Cells Yield Alveoli In Vitro and during Lung Regeneration following H1N1 Influenza Infection. Cell. 2011 Oct 28;147(3):525-38).
Q: What kind of success are you seeing these days with adipose treatments for rheumatoid arthritis, Chron's disease, pscoriatic arthritis and other similar auto immune diseases? Do you feel some level of immune suppression is necessary for the stem cell procedure to achieve lasting results in these type of autoimmune conditions?
A: Medistem only has two clinical programs: Critical limb ischemia in the USA with Indiana University (FDA approved) and Ischemic Congestive Heart Failure (Russian Regulatory Approval). However the licensees of our technologies for Central America (www.cellmedicine.com) have been reported, together with us, some excellent results in rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis. We do not feel that immune suppression is needed due to the nature of the cells being administered. For more information please read our joint paper on multiple sclerosis or rheumatoid arthritis, these are in peer reviewed journals but may be found on the Cellmedicine website.
Q: What types of stem cells are best for brain injury and neurological disease - bone marrow, adipose, induced plutipotent stem cells from the blood or cord blood derived stem cells (or some other type of stem cells)? Some doctors use neuron cells cultured from umbilical cord blood. Would this be best for healing neurological damage?
A: The answer to this question can only be known after Phase III placebo controlled trials. If I were to speculate, I would suggest a combination approach in which one cell type provides for de novo neurogenesis (eg neurotrophically stimulated placental or early stem cell), the other acts as a “feeder cell” (eg like an activated mesenchymal stem cell) and the other being an angiogenic cell (eg an ERC). In reality the major medical successes in this field I believe will involve combination approaches.
Q: Are there menstrual blood storage facilities like there are cord blood storage facilities? This source seems rather limited otherwise or do you expand them in some way that doesn't require continual new sources?
A: All of the cells that we are using are from donors that have been heavily screened (more thoroughly screen than if they were giving their organs). In the current FDA-approved production scheme, one donor makes 21,000 doses. There exists places where menstrual blood may be banked.
Q: Is Medistem associated with a clinic(s) where actual treatment for patients is given using Medistem's technology or is everything you are working on in the research and clinical trial stage? How will you recruit for your clinical trials?
A: Medistem’s Central American licensee (www.cellmedicine.com) is using Medistem’s technology under license. For our clinical trials in the US and Russia patients are referred from their doctors.
Q: Of all the different types of stem cell therapies available to the public right now for respiratory disease, which source do you feel is most likely to help a patient get some quality of life improvements? The sources that I know about are marrow, adipose, peripheral blood, embryonic, umbilical cord, placenta. What method of infusion do you feel is the best?
A: Again, this is the type of question where the real answer needs double blind placebo controlled studies. That said, if I was to speculate, I would say it depends on the respiratory condition. In situations like fibrosis, I would say the ERC has the most potential based on its tissue remodeling and anti-fibriotic activities. Embryonic I would definitely stay away from, not just because of cancer risk but also because of ectopic tissue (eg you may actually get abnormal tissues formed in lung). As to method of administration, IV is good because the majority of cells injected this way end up in lung.
Q: Do you someday foresee an "off the shelf" stem cell product that would be used for all kinds of conditions and diseases? If not, why not?
A: That is our corporate mission: an “off the shelf” product for critical limb ischemia and congestive heart failure. Of course dependent on the disease the cells may be tweaked either by culture conditions or other means, but overall, this is actually what we are working on. More can be learned about this on our website www.medisteminc.com.
Q: Is it true that when peripheral blood stem cells expand on their own that they lose their potency as they proliferate? If so, would this be true with other stem cell types as well?
A: Yes, all stem cells lose activity with more proliferation. The exception is embryonic stem cells, but they come with their own set of issues (eg cancer, ectopic growth, poor integration.
Q: Do you support ICMS and its goals?
A: We support all organizations that advocate on behalf of patients and try to accelerate clinical implementation of promising therapeutics.
Q: Would your company's (Medistem) endometrial stem cells (ERC) be good for disorders of the brain such as autism or cerebral palsy?
A: First before I begin, let me state that because Medistem is a public company with shares on the pink sheets (MEDS.PK), comments I make here are strictly my own and not necessarily representative of Medistem’s opinion. Additionally, comments here are not medical advice and may contain “forward-looking statements”.
Endometrial regenerative cells (ERC) are highly angiogenic and vasculogenic, meaning that they are useful in the production of new blood vessels in tissues that lack oxygen. In stroke, cells identical to ERC have been demonstrated to induce a potent therapeutic response (Borlongan et al. Menstrual blood cells display stem cell-like phenotypic markers and exert neuroprotection following transplantation in experimental stroke. Stem Cells Dev. 2010 Apr;19(4):439-52), since cerebral palsy has some similarities at a molecular and cellular level to stroke, there may be some rationale for their use. Other angiogenic stem cells, such as adipose stem cells, have been demonstrated to exert therapeutic responses in animal models of cerebral palsy (Wei et al. IFATS collection: The conditioned media of adipose stromal cells protect against hypoxia-ischemia-induced brain damage in neonatal rats. Stem Cells. 2009 Feb;27(2):478-88). Whether ERC will be useful clinically in these conditions requires clinical trials. Currently the company is highly focused on critical limb ischemia and congestive heart failure, for which we have FDA approval and Russian Regulatory approval for clinical trials.
Q: If stem cell therapy is attempted to rebuild emphysematous lungs, does that mean the inflation that has taken place is reversed as new alveoli and blood channels are (hopefully) created, so that in essence the lungs "shrink" back to a normal size? Or do they become more efficient, retrofitted as it were, with new functional tissue--but with the inflation staying the same? What do animal studies tell us?
A: It depends on the animal system used. There are some examples in which new alveoli have been demonstrated with stem cell administration. However the majority of experiments use the stem cells at the same time as the injury and show inhibition of progression of injury. In a recent paper the molecular basis of alveoli regeneration was demonstrated (Kumar et al. Distal Airway Stem Cells Yield Alveoli In Vitro and during Lung Regeneration following H1N1 Influenza Infection. Cell. 2011 Oct 28;147(3):525-38).
Q: What kind of success are you seeing these days with adipose treatments for rheumatoid arthritis, Chron's disease, pscoriatic arthritis and other similar auto immune diseases? Do you feel some level of immune suppression is necessary for the stem cell procedure to achieve lasting results in these type of autoimmune conditions?
A: Medistem only has two clinical programs: Critical limb ischemia in the USA with Indiana University (FDA approved) and Ischemic Congestive Heart Failure (Russian Regulatory Approval). However the licensees of our technologies for Central America (www.cellmedicine.com) have been reported, together with us, some excellent results in rheumatoid arthritis, psoriatic arthritis, and multiple sclerosis. We do not feel that immune suppression is needed due to the nature of the cells being administered. For more information please read our joint paper on multiple sclerosis or rheumatoid arthritis, these are in peer reviewed journals but may be found on the Cellmedicine website.
Q: What types of stem cells are best for brain injury and neurological disease - bone marrow, adipose, induced plutipotent stem cells from the blood or cord blood derived stem cells (or some other type of stem cells)? Some doctors use neuron cells cultured from umbilical cord blood. Would this be best for healing neurological damage?
A: The answer to this question can only be known after Phase III placebo controlled trials. If I were to speculate, I would suggest a combination approach in which one cell type provides for de novo neurogenesis (eg neurotrophically stimulated placental or early stem cell), the other acts as a “feeder cell” (eg like an activated mesenchymal stem cell) and the other being an angiogenic cell (eg an ERC). In reality the major medical successes in this field I believe will involve combination approaches.
Q: Are there menstrual blood storage facilities like there are cord blood storage facilities? This source seems rather limited otherwise or do you expand them in some way that doesn't require continual new sources?
A: All of the cells that we are using are from donors that have been heavily screened (more thoroughly screen than if they were giving their organs). In the current FDA-approved production scheme, one donor makes 21,000 doses. There exists places where menstrual blood may be banked.
Q: Is Medistem associated with a clinic(s) where actual treatment for patients is given using Medistem's technology or is everything you are working on in the research and clinical trial stage? How will you recruit for your clinical trials?
A: Medistem’s Central American licensee (www.cellmedicine.com) is using Medistem’s technology under license. For our clinical trials in the US and Russia patients are referred from their doctors.
Q: Of all the different types of stem cell therapies available to the public right now for respiratory disease, which source do you feel is most likely to help a patient get some quality of life improvements? The sources that I know about are marrow, adipose, peripheral blood, embryonic, umbilical cord, placenta. What method of infusion do you feel is the best?
A: Again, this is the type of question where the real answer needs double blind placebo controlled studies. That said, if I was to speculate, I would say it depends on the respiratory condition. In situations like fibrosis, I would say the ERC has the most potential based on its tissue remodeling and anti-fibriotic activities. Embryonic I would definitely stay away from, not just because of cancer risk but also because of ectopic tissue (eg you may actually get abnormal tissues formed in lung). As to method of administration, IV is good because the majority of cells injected this way end up in lung.
Q: Do you someday foresee an "off the shelf" stem cell product that would be used for all kinds of conditions and diseases? If not, why not?
A: That is our corporate mission: an “off the shelf” product for critical limb ischemia and congestive heart failure. Of course dependent on the disease the cells may be tweaked either by culture conditions or other means, but overall, this is actually what we are working on. More can be learned about this on our website www.medisteminc.com.
Q: Is it true that when peripheral blood stem cells expand on their own that they lose their potency as they proliferate? If so, would this be true with other stem cell types as well?
A: Yes, all stem cells lose activity with more proliferation. The exception is embryonic stem cells, but they come with their own set of issues (eg cancer, ectopic growth, poor integration.
Q: Do you support ICMS and its goals?
A: We support all organizations that advocate on behalf of patients and try to accelerate clinical implementation of promising therapeutics.