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This month's Ask the Doctor column is being hosted by Dr. Fabio Solano.
As always a big thank you to all our monthly host.
About the Doctor
Dr. Fabio Solano, M.D.
Dr. Solano is the Medical Director of the Institute for Cellular Medicine www.cellmedicine.com The doctor has world-wide experience in cellular medicine.
He conducted the first autologous antigen dendritic cell vaccine study for prostate cancer. He has served as a consultant to clinics conducting cell therapy in the U.S. (The Aidan Clinic), Mexico, the Bahamas and Costa Rica.
Doctor Solano maintains his surgical private practice at the CIMA Hospital, the largest private hospital in Costa Rica. CIMA is accredited by the Joint Commission, the same regulatory body that oversees U.S. hospitals. Dr. Solano has written scientific journal articles on stem cells that have been published in international journals.
Dr. Solano received his M.D. from the University of Costa Rica in 1969, and his Surgical Residency in 1974.
He completed post-graduated studies in advanced surgical techniques at the Manchester Royal Infirmary, Manchester, England from 1978 to 1980. He was appointed as Assistant Surgeon General at Mexico Hospital in 1992.
Dr. Solano has two grown children. He is an avid golfer and was President of the Costa Rica Golf association from 1992 to 2002
1) Do you think the benefits and improvements from stem cell therapy in the case of Autism will be maintained forever without requiring further treatments in the future?
Autism is a complex disorder with varying symptomatologies. Without doing formal randomized trials in which one subpopulation is investigated in a double-blind manner for years, it will be difficult to prove concrete responses or response durations.
That being said, so far the longest follow-up has been our first patient in November 2006. In this situation improvement went from being non verbal, to talking in a short period of time. The patient was also moved to a regular classroom, experiencing what appeared to be an almost a 100% recovery. The patient received three sessions of treatment. Obviously there are no guarantees that this is representative for everyone. We explain in detail the rationale and need for proper clinical trials of stem cells in autism in the peer reviewed publication ?Stem Cell Therapy for Autism? (Ichim et al. J Transl Med. 2007 Jun 27;5:30 link at http://www.translational-medicine.com/content/pdf/1479-5876-5-30.pdf )
Due to the multifactorial pathogenesis of autism, combination of stem cell therapy with various other interventions is recommended.
2) What are the issues with fetal stem cells? Do I have a reason to worry?
Fetal stem cells are potentially dangerous with at least one documented case of cancer occurring after administration of fetal stem cell therapy (Amariglio et al. PLoS Med. 2009 Feb 17;6(2): http://medicine.plosjournals.org/archive/1549-1676/6/2/pdf/10.1371_journal.pmed.1000029-S.pdf ).
Adult stem cells play a natural role in repair of damaged tissue in the adult in contrast, fetal stem cells do not properly ?know? how to communicate with adult tissue. It is this lack of proper integration that leads to ability of the fetal cells to escape normal ?self restrain? signals and allows them to start multiplying uncontrollably, which then may lead to formation of cancer.
It should be noted that for embryonic stem cells, the definition is a cell that can cause a teratoma (type of cancer) in an immune deficient animal. Thus formation of cancer by embryonic stem cells is not just ?a possible side effect?, but an intrinsic property of the cells themselves. (emphasis added by Administrator)
If you go on www.pubmed.com and type in the words ?embryonic stem cell? and ?teratoma? you will see.
Another disadvantage of fetal and embryonic stem cell therapy is that the cells are either completely undifferentiated, which does not allow them to home properly to damaged tissue, or when they are administrated as differentiated cells, the immune system of the recipient starts to kill them because they are seen as ?foreign?. The current US clinical trial of embryonic stem cells by the company Geron requires recipients to receive immune suppression so as to not reject the embryonic stem cell-derived neurons.
A type of adult stem cell, the mesenchymal stem cell, or MSC, is approved already in the U.S. for one indication?bone repair and is in phase III and phase II trials for other indications. The MSC does not form tumors and has shown benefit to the patient without immune suppression.
3) Would a baclofen pump interfere with or lessen the result of a stem cell treatment? Stem cell treatment would be 6 months after baclofen pump surgery.
Conceptually no, the medication itself does not interfere, this would be for MS cases or Cerebral Palsy in which the patient requires a microdose of the medication constantly for muscle spasms. For intrathecal injections fluoroscopy is required to avoid the puncture of the pump catheter. Other medications, such as immune suppressants are contraindicated.
4-5) Do you have any clinical experience of effective tissue regeneration of the lung tissue using any stem cell therapies? If yes, how many and what percent of regeneration was accomplished? What are your future recommendations for lung regeneration? I guess I'm kind of interested in this area for some reason.
This is not an area that I focus on. I have a few local patients, one of whom has shown some improvement after multiple treatments. Our core competencies are treating people with multiple sclerosis, spinal cord injury, autism, cerebral palsy, and heart failure.
6) Are you currently using any treatments that combine gene therapy with stem cell therapy? If so, can you elaborate a little as to what diseases are responding to this type of treatment?
No. Gene therapy offers tremendous potential, however, presently there are still issues with controlling expression of genes, as well as possible interactions. The approach of using stem cells is based on the philosophy of providing ?repair cells? that theoretically would be superior to gene therapy since the cells intrinsically express the ?symphony of cytokines? that are required for acceleration of healing.
In the future, one gene therapy that will be available is administration of chemo attractant genes to areas where organ healing is desired. Chemo attractants are chemicals that attract stem cells at higher concentrations than normal.
7) Have any of the patients you have that received treatment for COPD been able to get off of supplemental oxygen and stay off of it? If so, how many treatments did it take to accomplish this and how severe was the COPD?
The one patient I mentioned above was not entirely oxygen depended. He received 6 treatments over 1.5 years. He is local. This is why I do not normally accept any COPD patients?I believe they need many treatments to achieve a significant benefit.
8) Do you only treat with umbilical cord stem cells or do you also use autologous stem cells? What decides which type of cells should be used on what disease if you use both types of therapy?
We have used autologous adipose (fat) derived cells for autoimmune diseases such as MS, Crohn?s disease, and rheumatoid arthritis. We have also used them for osteoarthritis and degenerative hip disorders. Typically a non-purified cellular mix isolated from liposuctioned fat is used. It is called the stromal vascular fraction, or SVF and contains MSCs, T regulatory cells. Both of these cells ?tolerize? the immune system, so, in cases of autoimmune disease we are trying to treat the dysregulated immune system, not necessarily repair of tissue.
In a recent paper from Northwestern University, they reported benefit in MS patients by isolating the patient?s own stem cells, giving them chemotherapy to wipe out the offending T-cells and then giving back the harvested stem cells. We attempt to correct the immune system by just using the cells, we do not use chemotherapy.
We have also used autologous bone marrow for people with type II diabetes, limb ischemia, and kidney failure. The type or types of cells we used are based on the pathophysiology of the disease and the known actions of the cell types we use.
9) I have Lyme disease. Any hope for this?
I do not know of any rationale for the use of stem cells in the treatment of Lyme.
10) Please describe your program for MS.
Our treatment plan consists of two separate types of injections: intrathecal injections using umbilical cord derived CD34+ cells as well as mesenchymal cells obtained from umbilical cord matrix administered on separate intrathecal injections.
Autologous (the patient?s own) fat derived stromal vascular fraction (described above) are used based on their content of T regulatory cells which inhibit pathological immune reactions, as well as mesenchymal stem cells, known to induce immune tolerance and accelerate remyelination. The attractive feature of fat stem cells is that they are easy to extract and can be stored for future use.
Fat stem cells have been used to treat >3000 race horses and thousands of companion animals for not only orthopedic conditions, but also for inflammatory disorders such as Rheumatoid Arthritis. The mesenchymal stem cells that are found in fat are similar to mesenchymal stem cells found in bone marrow, which have been clinically used for treatment of conditions associated with deregulated immune system such as graft versus host disease (GVHD).
11. A number of CP children treated by Dr. Joanne Kurtzberg are nearly 'cured'. This was when they had their own cord blood. What I fail to understand is why are those who use donated cord blood not show even half that improvement though the quantity given to them can be more than Dr. Joanne used from a single cord blood unit? Does the potency of donated cord blood reduce by the process with which it becomes usable on others? Every CP mom and dad want their children to improve as much as Dallas Hextell, Chloe Levine and Ryan Schneider did! Yet multiple vials of cord blood don?t have the same effect. Dr. Rader, Ramirez, Finerman, Cell Medicine - none of them has been able to come up with what Dr. Joanne has done. Dr. Joanne injects 10 - 50 million cells per kg of body weight. Thus a 10 kg baby would get approx 500 million cells (including mononuclear cells). This quantity has been specified to me by Dr. Joanne herself.
It is my understanding that Dr. Kurtzberg is using whole autologous cord blood mononuclear cells. These cells were collected at the time of birth and cryopreserved. The mononuclear cells of the cord are much more numerous than the stem cells. For example a typical umbilical cord blood sample has only around 1 million CD34+ stem cells in it and the mononuclear cells number in the hundreds of millions.
The mononuclear cells contain other stem- and progenitor cells such as MSC and endothelial precursor cells and potentially unknown other cells which could have an additive or even synergistic effect. I believe most people are using only isolated and expanded CD34+ cells. It would be very interesting to see the data of Dr. Kurtzberg which I do not believe have been published yet. This makes comparison of data very nearly impossible.
There are more and more examples in the literature and in my practice showing synergistic effects of multiple stem cell types. I have a number of CP patients with positive results, again, they can not be compared until they fully characterized and published.
About the company
Cell Medicine is currently referring patients for treatment with Autoimmune Diseases, Cerebral Palsy, Critical Limb Ischemia, Degenerative Joint Disease, Diabetes Type II, Heart Failure, Multiple Sclerosis, Osteoarthritis, Rheumatoid Arthritis and Spinal Injury.
Cell Medicine advocates the use of autologous stem cells as they have no ethical or moral issues and pose no possibility for rejection since they come from the patient. According to various studies, stem cells isolated from a patient (i.e. from the bone marrow or fat) have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells, and cartilage cells). Studies have also shown that these are capable of "homing in" on and repairing damaged tissue.
Cell Medicine only advocates the use of stem cells derived from the non-controversial sources: bone marrow, muscle, skin, fat and blood.
Interested persons should visit the website at www.cellmedicine.com or call 1-800-980-STEM from the U.S. or 1-954-636-3390 from outside North America.
As always a big thank you to all our monthly host.
About the Doctor
Dr. Fabio Solano, M.D.
Dr. Solano is the Medical Director of the Institute for Cellular Medicine www.cellmedicine.com The doctor has world-wide experience in cellular medicine.
He conducted the first autologous antigen dendritic cell vaccine study for prostate cancer. He has served as a consultant to clinics conducting cell therapy in the U.S. (The Aidan Clinic), Mexico, the Bahamas and Costa Rica.
Doctor Solano maintains his surgical private practice at the CIMA Hospital, the largest private hospital in Costa Rica. CIMA is accredited by the Joint Commission, the same regulatory body that oversees U.S. hospitals. Dr. Solano has written scientific journal articles on stem cells that have been published in international journals.
Dr. Solano received his M.D. from the University of Costa Rica in 1969, and his Surgical Residency in 1974.
He completed post-graduated studies in advanced surgical techniques at the Manchester Royal Infirmary, Manchester, England from 1978 to 1980. He was appointed as Assistant Surgeon General at Mexico Hospital in 1992.
Dr. Solano has two grown children. He is an avid golfer and was President of the Costa Rica Golf association from 1992 to 2002
1) Do you think the benefits and improvements from stem cell therapy in the case of Autism will be maintained forever without requiring further treatments in the future?
Autism is a complex disorder with varying symptomatologies. Without doing formal randomized trials in which one subpopulation is investigated in a double-blind manner for years, it will be difficult to prove concrete responses or response durations.
That being said, so far the longest follow-up has been our first patient in November 2006. In this situation improvement went from being non verbal, to talking in a short period of time. The patient was also moved to a regular classroom, experiencing what appeared to be an almost a 100% recovery. The patient received three sessions of treatment. Obviously there are no guarantees that this is representative for everyone. We explain in detail the rationale and need for proper clinical trials of stem cells in autism in the peer reviewed publication ?Stem Cell Therapy for Autism? (Ichim et al. J Transl Med. 2007 Jun 27;5:30 link at http://www.translational-medicine.com/content/pdf/1479-5876-5-30.pdf )
Due to the multifactorial pathogenesis of autism, combination of stem cell therapy with various other interventions is recommended.
2) What are the issues with fetal stem cells? Do I have a reason to worry?
Fetal stem cells are potentially dangerous with at least one documented case of cancer occurring after administration of fetal stem cell therapy (Amariglio et al. PLoS Med. 2009 Feb 17;6(2): http://medicine.plosjournals.org/archive/1549-1676/6/2/pdf/10.1371_journal.pmed.1000029-S.pdf ).
Adult stem cells play a natural role in repair of damaged tissue in the adult in contrast, fetal stem cells do not properly ?know? how to communicate with adult tissue. It is this lack of proper integration that leads to ability of the fetal cells to escape normal ?self restrain? signals and allows them to start multiplying uncontrollably, which then may lead to formation of cancer.
It should be noted that for embryonic stem cells, the definition is a cell that can cause a teratoma (type of cancer) in an immune deficient animal. Thus formation of cancer by embryonic stem cells is not just ?a possible side effect?, but an intrinsic property of the cells themselves. (emphasis added by Administrator)
If you go on www.pubmed.com and type in the words ?embryonic stem cell? and ?teratoma? you will see.
Another disadvantage of fetal and embryonic stem cell therapy is that the cells are either completely undifferentiated, which does not allow them to home properly to damaged tissue, or when they are administrated as differentiated cells, the immune system of the recipient starts to kill them because they are seen as ?foreign?. The current US clinical trial of embryonic stem cells by the company Geron requires recipients to receive immune suppression so as to not reject the embryonic stem cell-derived neurons.
A type of adult stem cell, the mesenchymal stem cell, or MSC, is approved already in the U.S. for one indication?bone repair and is in phase III and phase II trials for other indications. The MSC does not form tumors and has shown benefit to the patient without immune suppression.
3) Would a baclofen pump interfere with or lessen the result of a stem cell treatment? Stem cell treatment would be 6 months after baclofen pump surgery.
Conceptually no, the medication itself does not interfere, this would be for MS cases or Cerebral Palsy in which the patient requires a microdose of the medication constantly for muscle spasms. For intrathecal injections fluoroscopy is required to avoid the puncture of the pump catheter. Other medications, such as immune suppressants are contraindicated.
4-5) Do you have any clinical experience of effective tissue regeneration of the lung tissue using any stem cell therapies? If yes, how many and what percent of regeneration was accomplished? What are your future recommendations for lung regeneration? I guess I'm kind of interested in this area for some reason.
This is not an area that I focus on. I have a few local patients, one of whom has shown some improvement after multiple treatments. Our core competencies are treating people with multiple sclerosis, spinal cord injury, autism, cerebral palsy, and heart failure.
6) Are you currently using any treatments that combine gene therapy with stem cell therapy? If so, can you elaborate a little as to what diseases are responding to this type of treatment?
No. Gene therapy offers tremendous potential, however, presently there are still issues with controlling expression of genes, as well as possible interactions. The approach of using stem cells is based on the philosophy of providing ?repair cells? that theoretically would be superior to gene therapy since the cells intrinsically express the ?symphony of cytokines? that are required for acceleration of healing.
In the future, one gene therapy that will be available is administration of chemo attractant genes to areas where organ healing is desired. Chemo attractants are chemicals that attract stem cells at higher concentrations than normal.
7) Have any of the patients you have that received treatment for COPD been able to get off of supplemental oxygen and stay off of it? If so, how many treatments did it take to accomplish this and how severe was the COPD?
The one patient I mentioned above was not entirely oxygen depended. He received 6 treatments over 1.5 years. He is local. This is why I do not normally accept any COPD patients?I believe they need many treatments to achieve a significant benefit.
8) Do you only treat with umbilical cord stem cells or do you also use autologous stem cells? What decides which type of cells should be used on what disease if you use both types of therapy?
We have used autologous adipose (fat) derived cells for autoimmune diseases such as MS, Crohn?s disease, and rheumatoid arthritis. We have also used them for osteoarthritis and degenerative hip disorders. Typically a non-purified cellular mix isolated from liposuctioned fat is used. It is called the stromal vascular fraction, or SVF and contains MSCs, T regulatory cells. Both of these cells ?tolerize? the immune system, so, in cases of autoimmune disease we are trying to treat the dysregulated immune system, not necessarily repair of tissue.
In a recent paper from Northwestern University, they reported benefit in MS patients by isolating the patient?s own stem cells, giving them chemotherapy to wipe out the offending T-cells and then giving back the harvested stem cells. We attempt to correct the immune system by just using the cells, we do not use chemotherapy.
We have also used autologous bone marrow for people with type II diabetes, limb ischemia, and kidney failure. The type or types of cells we used are based on the pathophysiology of the disease and the known actions of the cell types we use.
9) I have Lyme disease. Any hope for this?
I do not know of any rationale for the use of stem cells in the treatment of Lyme.
10) Please describe your program for MS.
Our treatment plan consists of two separate types of injections: intrathecal injections using umbilical cord derived CD34+ cells as well as mesenchymal cells obtained from umbilical cord matrix administered on separate intrathecal injections.
Autologous (the patient?s own) fat derived stromal vascular fraction (described above) are used based on their content of T regulatory cells which inhibit pathological immune reactions, as well as mesenchymal stem cells, known to induce immune tolerance and accelerate remyelination. The attractive feature of fat stem cells is that they are easy to extract and can be stored for future use.
Fat stem cells have been used to treat >3000 race horses and thousands of companion animals for not only orthopedic conditions, but also for inflammatory disorders such as Rheumatoid Arthritis. The mesenchymal stem cells that are found in fat are similar to mesenchymal stem cells found in bone marrow, which have been clinically used for treatment of conditions associated with deregulated immune system such as graft versus host disease (GVHD).
11. A number of CP children treated by Dr. Joanne Kurtzberg are nearly 'cured'. This was when they had their own cord blood. What I fail to understand is why are those who use donated cord blood not show even half that improvement though the quantity given to them can be more than Dr. Joanne used from a single cord blood unit? Does the potency of donated cord blood reduce by the process with which it becomes usable on others? Every CP mom and dad want their children to improve as much as Dallas Hextell, Chloe Levine and Ryan Schneider did! Yet multiple vials of cord blood don?t have the same effect. Dr. Rader, Ramirez, Finerman, Cell Medicine - none of them has been able to come up with what Dr. Joanne has done. Dr. Joanne injects 10 - 50 million cells per kg of body weight. Thus a 10 kg baby would get approx 500 million cells (including mononuclear cells). This quantity has been specified to me by Dr. Joanne herself.
It is my understanding that Dr. Kurtzberg is using whole autologous cord blood mononuclear cells. These cells were collected at the time of birth and cryopreserved. The mononuclear cells of the cord are much more numerous than the stem cells. For example a typical umbilical cord blood sample has only around 1 million CD34+ stem cells in it and the mononuclear cells number in the hundreds of millions.
The mononuclear cells contain other stem- and progenitor cells such as MSC and endothelial precursor cells and potentially unknown other cells which could have an additive or even synergistic effect. I believe most people are using only isolated and expanded CD34+ cells. It would be very interesting to see the data of Dr. Kurtzberg which I do not believe have been published yet. This makes comparison of data very nearly impossible.
There are more and more examples in the literature and in my practice showing synergistic effects of multiple stem cell types. I have a number of CP patients with positive results, again, they can not be compared until they fully characterized and published.
About the company
Cell Medicine is currently referring patients for treatment with Autoimmune Diseases, Cerebral Palsy, Critical Limb Ischemia, Degenerative Joint Disease, Diabetes Type II, Heart Failure, Multiple Sclerosis, Osteoarthritis, Rheumatoid Arthritis and Spinal Injury.
Cell Medicine advocates the use of autologous stem cells as they have no ethical or moral issues and pose no possibility for rejection since they come from the patient. According to various studies, stem cells isolated from a patient (i.e. from the bone marrow or fat) have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells, and cartilage cells). Studies have also shown that these are capable of "homing in" on and repairing damaged tissue.
Cell Medicine only advocates the use of stem cells derived from the non-controversial sources: bone marrow, muscle, skin, fat and blood.
Interested persons should visit the website at www.cellmedicine.com or call 1-800-980-STEM from the U.S. or 1-954-636-3390 from outside North America.