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Chairman – Education Committee  Indian Spinal Injuries Centre Chief of Spine Service & Medical Director Cellular Therapies (Including Stem Cell  treatment) for  Human SCI Fact Fiction? or International Spinal Cord Society
Korean Scientists Succeed in Stem Cell Therapy,  Korea Times , 11.26.2004 In South Korea, multi-potent stem cells from umbilical cord blood were reportedly transplanted into a 37 year old woman who had not been able to stand up in 19 years due to a gymnastics accident.   Three weeks later she was apparently able to walk using a walker.
Press report – Beneficiary of Adult Stem Cell treatment for SCI & Paralysis Testimony at Senate Committee on Science, Technology, and Space Hearing: Adult Stem Cell Research, Wednesday, July 14 2004 by Laura Dominguez My name is Laura Dominguez. I am 19 years old and live in San Antonio, TX. Three years ago, while on the way home from summer school, my brother and I were involved in a car accident that left me paralyzed from the neck down.  The accident was caused by an oil spill on the highway. An oil spill that we had nothing to do with, but by chance was on the roadway in our lane. I suffered a C6 vertebrae burst fracture and my spinal cord was severely damaged. At that time doctors gave me absolutely no chance of ever walking again. I refused to accept their prognosis and began searching for other options. After being hospitalized (in several hospitals) for almost a year, my mother and I relocated to San Diego, CA so that I could undergo extensive physical therapy. While in California, we met a family whose daughter was suffering from a similar spinal cord injury. They were also looking for other alternatives to deal with spinal cord injuries.   After extensive research and consultations with medical experts in the field of spinal cord injuries, we decided the best procedure, that exists today, was being performed in Portugal.   We teamed up with the Nader family, a group of Doctors from the Detroit Medical Center, and flew to Portugal to undergo this new surgical procedure. The surgery involved the removal of tissue from my olfactory sinus area and transplanting it into my spinal cord at the injury site. Both procedures, the harvesting of the tissue and the transplant were done at the same time. I was the tenth person in the world and the second American to have this procedure done. After the surgery, I returned to California to continue physical therapy. I stayed there until July of 2003 and then returned back to San Antonio, TX. At that time an MRI was taken and it revealed my spinal cord had begun to heal. Approximately 70% of the lesion now looked like normal spinal cord tissue. I was also starting to regain feeling in my upper body and within six months I had regained feeling down to my abdomen. Improvements in my sensory feelings have continued until the present time. I can now feel down to my hip level and have started to regain feeling and some movement down to my legs. My upper body has gained more strength and balance. Another one of the most evident improvements has been my ability to stand and remain standing, using a walker, and with minimal assistance. When I stand I can contract my quadriceps and hamstring muscles. I can also stand on my toes when I am on my feet. And more importantly, while lying down in a prone position, I am able to move my feet. My training has continued to this day and I am able to better use the muscles in my hip area.   I am able, with assistance and the use of braces, to walk a distance of over 1400 feet.   It takes approximately thirty minutes to walk this distance and it is extremely tiring, but it can be done. I will continue to challenge myself until I can fully walk again with little or no assistance from braces or the help of a therapist. I hope…no, I know…this will be possible by my 21st birthday. It is my understanding that the nervous system is one of the most difficult and complex to repair after an injury or trauma. But in my case, the procedure that was performed in Portugal is working as I have regained more feeling and movement. Some of the movements that I am able to make are functions that are controlled by the very tip of my spinal cord. Although the intensive physical training that I had enhanced my ability to regain strength and movement, prior to surgery I did not have the type of function and feeling that I have now. It only stands to reason that if adult stem cells can repair the complex functions of the spinal cord, they can repair and help other injured internal organs or other parts of the body, whether an injury is caused by trauma or disease. The way I see it, scientists have been given the knowledge and tools to develop and make use of adult stem cells, whether they are derived from tissue removed from the olfactory mucosa or otherwise. This knowledge should be taken full advantage of to help people overcome injuries that can be helped by stem cells or people that suffer from some terminal or debilitating diseases. At the very least, some people can benefit from the possibility of a better quality of life.
Dr ##### ####### cultivates the cells of aborted foetuses and injects them into the brains and spines of his patients. His method is controversial, but   his results have led hundreds of westerners to his Beijing surgery .  Jonathan Watts was given unprecedented access to the doctor and his patients  Wednesday December 1, 2004 The Guardian A clinic in China has become the focus of a medical pilgrimage for paraplegics, tetraplegics and amyotrophic lateral sclerosis sufferers from across the western world. Doctor  ##### #######   of the Xinshan hospital in Beijing is the only doctor in the world known to be pioneering a new controversial surgical procedure - using the nasal cells from aborted foetuses.  For the first time ever, Dr Huang has permitted TV cameras inside his operating theatre and this unique film records the extraordinary surgical process.  Guardianfilms now presents an extract from this report, to be broadcast tonight, December 1, at 10.30pm on  BBC Newsnight . The film is distributed by  Journeyman Pictures . China's medical Mecca
A  25 year old Akbar ali, who sustained an injury to his spinal cord on the 12th of October 2006 at a construction site in Abhudabi following a fall from 12 mts, lost sensation and activity of the lower half of his body. He was treated surgically in which the bones of the vertebral column within which the spinal cord is situated were fixed using metal plates and screws after which he was on a wheel chair without any control over his bladder and bowel. The sensation and activity also didn't improve much. He arrived back in India on a wheel chair in the first week of December 2006. Incidentally when he got admitted to the #### #### Hospital, Chennai, for a reparative surgery to correct the bowel sphincter, the hospital had just got a MoU signed with NCRM for a collaborative work on stem cell based clinical applications. Immediately his case was considered for the stem cell therapy as the time elapsed from the accident until then was very short (10 weeks)  Two months after treatment, Ali was now able to walk on his own and had also regained good sensation in the legs.   He did not need a catheter and could pass urine intermittently every two hours, Dr ######### said. Crippling Spinal Cord Injuries could soon be treated at the country’s first stem cell transplant centre
Legends
Fact !!!!!!!!!!! or Fiction ????????
Why the confusion ? ,[object Object],[object Object],[object Object],[object Object]
Why the confusion ? ,[object Object],[object Object],[object Object],[object Object]
Pathophysiology of Spinal cord injury ,[object Object],[object Object],But even with minimal disturbance to the tract glial framework, the sprouts did not reenter the distal part of the tract. (Davies et al, 1996)
Pathophysiology & natural history  of SCI is different ; hence management strategies & outcomes are different
Why the confusion ? ,[object Object],[object Object],[object Object],[object Object]
Cell based approaches to treat spinal cord injury: ,[object Object],[object Object]
Cell based approaches to treat spinal cord injury ,[object Object],[object Object],[object Object]
Methods used in Replacement Cell Therapy / Stem Cell Research in SCI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical trials using Stem Cells (ESCs) From Xenografts ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical trials using Human Fetal Spinal Cord (? Embryonic Stem Cells From Fetus) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical trials using Umbilical Cord Blood Stem Cells ,[object Object],[object Object],[object Object]
Adult Neural Stem Cells  ,[object Object]
Clinical trials using Adult Marrow Stem Cells: ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2007
Stem Cell Research ,[object Object],[object Object]
Methods used in Regenerative Cell Therapy in SCI ,[object Object],[object Object],[object Object],[object Object],[object Object]
Peripheral Nerve Grafts ,[object Object],[object Object],[object Object]
Schwann Cell Cultures ,[object Object]
Activated Macrophages ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object]
Major problem in Regenerative cell therapy for SCI: ,[object Object],[object Object]
Excerpts from “Olfactory ensheathing  cells and spinal cord repair” Alan Mackay-Sim,  Institute for Cell and Molecular Therapies, Griffith University, Brisbane, Qld, Australia; 2004 ,[object Object]
OEG Cells for Human SCI ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Brain (2005) Autologous olfactory ensheathing cell transplantation in human paraplegia: a 3-year clinical trial A. Mackay-Sim et al Brain (2008)
Autologous mucosal transplant in chronic spinal cord injury – an Indian Pilot Study H S Chhabra et al ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Spinal Cord, December, 2009
Autologous bone marrow transplantation in acute spinal cord injury – an Indian Pilot Study H S Chhabra et al ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],The Confusion
The Confusion ,[object Object],[object Object],[object Object],[object Object],[object Object]
Why the confusion ? ,[object Object],[object Object],[object Object],[object Object]
Need for Proper Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Natural progression of SCI JW Fawcett et al: Spontaneous recovery after SCI and statistical power needed for therapeutic clinical trials; Spinal Cord; 2007
Natural progression of SCI JW Fawcett et al: Spontaneous recovery after SCI and statistical power needed for therapeutic clinical trials; Spinal Cord; 2007
Subject bias ,[object Object],[object Object],[object Object]
Observer bias ,[object Object],[object Object]
Plasticity of Spinal Cord ,[object Object],[object Object]
Effects of Delayed Decompression ,[object Object],[object Object],[object Object],[object Object]
How the confusion effects patients ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Adverse effects of Cellular Therapies
[object Object],[object Object],Adverse effects of Cellular Therapies
Stem cell march, minus checks - Lack of research rules allows doctors to do as they like  G.S. MUDUR   Ajit Jogi and Dr Geeta Shroff at the news conference in New Delhi. Picture by Ramakant Kushwaha  New Delhi, Nov. 16: Flaws in rules for medical research and a failure of government agencies to exercise their watchdog rights have facilitated controversial human embryonic stem cell studies in India, scientists have said. As reported in The Telegraph today, government officials and senior scientists have questioned claims by a Delhi-based doctor that she has used embryonic stem cell to treat nearly 100 patients with different diseases or injuries. The claims by fertility specialist Geeta Shroff, made at a news conference here today, have attracted widespread criticism from scientists who have warned that embryonic stem cell technology is not mature enough for applications in humans. Health secretary Prasanna Hota, chief guest at the conference, said his presence should not be construed as an endorsement of the work. “But sometimes, scientific knowledge cannot wait for bureaucratic apparatus,” Hota said. However, reacting to claims by Shroff, scientists have said the absence of regulatory oversight allows virtually unfettered research by the private sector in India. “It looks like anyone can do anything in medical research,” said Satish Totey, director of stem cell research at Manipal Hospital in Bangalore. “Is this the message India wants to give to the world?” One concern among scientists is that embryonic stem cell may carry the risk of tumours. Shroff has asserted that she has not broken any law. “We’re not doing anything unethical. If the ICMR tells us to stop, we will stop,” she said. Top ICMR officials said they had written to Shroff that her work did not have their approval. Existing guidelines on medical ethics make it mandatory for doctors to seek approval from the Indian Council of Medical Research for such research, but there is nothing it can do when private doctors flout guidelines. “Guidelines are only guidelines. Any violations cannot be punished,” said Dorairajan Balasubramanian, research director at the LV Prasad Eye Institute in Hyderabad, himself involved in the use of stem cell to treat eye diseases. The ICMR and the Department of Biotechnology are working to tighten stem cell research rules, but researchers believe progress has been slow. “They should have acted five years ago,” said Totey. Shroff, who got MP Ajit Jogi and other patients to talk about their experiences with her therapy at the conference, said she has informed the ICMR. But ICMR officials said Shroff had only sent details of her patients. “We don’t need patient information for approval process. We have asked for protocols ? things like patient selection criteria, the source of the embryonic stem cell, the method of injecting them and the dosage,” they said. Some stem cell researchers fear a regulatory backlash. “The rules may now become so tight that we’ll find it hard to work,” Totey said. While the ICMR has drafted legislation to make medical ethics mandatory for all, a senior official said it was hard to predict when it would come into effect. It has been cleared by the law ministry and is awaiting cabinet approval,” said Vasantha Muthuswamy, the head of basic medical sciences at the ICMR.
International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP) Member Organizations:
 
ICMR Guidelines for Clinical Research
Cellular Therapies in Human SCI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cellular Therapies in Human SCI ,[object Object],[object Object]
Cellular Therapies in Human SCI ,[object Object],[object Object]
Cellular Therapies in Human SCI ,[object Object],[object Object]
 
Medical Director Indian Spinal Injuries Centre Chief of Spine Service &

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Cellular Therapies (Including Stem Cell treatment) for Human SCI

  • 1. Chairman – Education Committee Indian Spinal Injuries Centre Chief of Spine Service & Medical Director Cellular Therapies (Including Stem Cell treatment) for Human SCI Fact Fiction? or International Spinal Cord Society
  • 2. Korean Scientists Succeed in Stem Cell Therapy, Korea Times , 11.26.2004 In South Korea, multi-potent stem cells from umbilical cord blood were reportedly transplanted into a 37 year old woman who had not been able to stand up in 19 years due to a gymnastics accident. Three weeks later she was apparently able to walk using a walker.
  • 3. Press report – Beneficiary of Adult Stem Cell treatment for SCI & Paralysis Testimony at Senate Committee on Science, Technology, and Space Hearing: Adult Stem Cell Research, Wednesday, July 14 2004 by Laura Dominguez My name is Laura Dominguez. I am 19 years old and live in San Antonio, TX. Three years ago, while on the way home from summer school, my brother and I were involved in a car accident that left me paralyzed from the neck down. The accident was caused by an oil spill on the highway. An oil spill that we had nothing to do with, but by chance was on the roadway in our lane. I suffered a C6 vertebrae burst fracture and my spinal cord was severely damaged. At that time doctors gave me absolutely no chance of ever walking again. I refused to accept their prognosis and began searching for other options. After being hospitalized (in several hospitals) for almost a year, my mother and I relocated to San Diego, CA so that I could undergo extensive physical therapy. While in California, we met a family whose daughter was suffering from a similar spinal cord injury. They were also looking for other alternatives to deal with spinal cord injuries. After extensive research and consultations with medical experts in the field of spinal cord injuries, we decided the best procedure, that exists today, was being performed in Portugal. We teamed up with the Nader family, a group of Doctors from the Detroit Medical Center, and flew to Portugal to undergo this new surgical procedure. The surgery involved the removal of tissue from my olfactory sinus area and transplanting it into my spinal cord at the injury site. Both procedures, the harvesting of the tissue and the transplant were done at the same time. I was the tenth person in the world and the second American to have this procedure done. After the surgery, I returned to California to continue physical therapy. I stayed there until July of 2003 and then returned back to San Antonio, TX. At that time an MRI was taken and it revealed my spinal cord had begun to heal. Approximately 70% of the lesion now looked like normal spinal cord tissue. I was also starting to regain feeling in my upper body and within six months I had regained feeling down to my abdomen. Improvements in my sensory feelings have continued until the present time. I can now feel down to my hip level and have started to regain feeling and some movement down to my legs. My upper body has gained more strength and balance. Another one of the most evident improvements has been my ability to stand and remain standing, using a walker, and with minimal assistance. When I stand I can contract my quadriceps and hamstring muscles. I can also stand on my toes when I am on my feet. And more importantly, while lying down in a prone position, I am able to move my feet. My training has continued to this day and I am able to better use the muscles in my hip area. I am able, with assistance and the use of braces, to walk a distance of over 1400 feet. It takes approximately thirty minutes to walk this distance and it is extremely tiring, but it can be done. I will continue to challenge myself until I can fully walk again with little or no assistance from braces or the help of a therapist. I hope…no, I know…this will be possible by my 21st birthday. It is my understanding that the nervous system is one of the most difficult and complex to repair after an injury or trauma. But in my case, the procedure that was performed in Portugal is working as I have regained more feeling and movement. Some of the movements that I am able to make are functions that are controlled by the very tip of my spinal cord. Although the intensive physical training that I had enhanced my ability to regain strength and movement, prior to surgery I did not have the type of function and feeling that I have now. It only stands to reason that if adult stem cells can repair the complex functions of the spinal cord, they can repair and help other injured internal organs or other parts of the body, whether an injury is caused by trauma or disease. The way I see it, scientists have been given the knowledge and tools to develop and make use of adult stem cells, whether they are derived from tissue removed from the olfactory mucosa or otherwise. This knowledge should be taken full advantage of to help people overcome injuries that can be helped by stem cells or people that suffer from some terminal or debilitating diseases. At the very least, some people can benefit from the possibility of a better quality of life.
  • 4. Dr ##### ####### cultivates the cells of aborted foetuses and injects them into the brains and spines of his patients. His method is controversial, but his results have led hundreds of westerners to his Beijing surgery . Jonathan Watts was given unprecedented access to the doctor and his patients Wednesday December 1, 2004 The Guardian A clinic in China has become the focus of a medical pilgrimage for paraplegics, tetraplegics and amyotrophic lateral sclerosis sufferers from across the western world. Doctor ##### ####### of the Xinshan hospital in Beijing is the only doctor in the world known to be pioneering a new controversial surgical procedure - using the nasal cells from aborted foetuses. For the first time ever, Dr Huang has permitted TV cameras inside his operating theatre and this unique film records the extraordinary surgical process. Guardianfilms now presents an extract from this report, to be broadcast tonight, December 1, at 10.30pm on BBC Newsnight . The film is distributed by Journeyman Pictures . China's medical Mecca
  • 5. A 25 year old Akbar ali, who sustained an injury to his spinal cord on the 12th of October 2006 at a construction site in Abhudabi following a fall from 12 mts, lost sensation and activity of the lower half of his body. He was treated surgically in which the bones of the vertebral column within which the spinal cord is situated were fixed using metal plates and screws after which he was on a wheel chair without any control over his bladder and bowel. The sensation and activity also didn't improve much. He arrived back in India on a wheel chair in the first week of December 2006. Incidentally when he got admitted to the #### #### Hospital, Chennai, for a reparative surgery to correct the bowel sphincter, the hospital had just got a MoU signed with NCRM for a collaborative work on stem cell based clinical applications. Immediately his case was considered for the stem cell therapy as the time elapsed from the accident until then was very short (10 weeks) Two months after treatment, Ali was now able to walk on his own and had also regained good sensation in the legs. He did not need a catheter and could pass urine intermittently every two hours, Dr ######### said. Crippling Spinal Cord Injuries could soon be treated at the country’s first stem cell transplant centre
  • 7. Fact !!!!!!!!!!! or Fiction ????????
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  • 11. Pathophysiology & natural history of SCI is different ; hence management strategies & outcomes are different
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  • 44. Natural progression of SCI JW Fawcett et al: Spontaneous recovery after SCI and statistical power needed for therapeutic clinical trials; Spinal Cord; 2007
  • 45. Natural progression of SCI JW Fawcett et al: Spontaneous recovery after SCI and statistical power needed for therapeutic clinical trials; Spinal Cord; 2007
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  • 53. Stem cell march, minus checks - Lack of research rules allows doctors to do as they like G.S. MUDUR Ajit Jogi and Dr Geeta Shroff at the news conference in New Delhi. Picture by Ramakant Kushwaha New Delhi, Nov. 16: Flaws in rules for medical research and a failure of government agencies to exercise their watchdog rights have facilitated controversial human embryonic stem cell studies in India, scientists have said. As reported in The Telegraph today, government officials and senior scientists have questioned claims by a Delhi-based doctor that she has used embryonic stem cell to treat nearly 100 patients with different diseases or injuries. The claims by fertility specialist Geeta Shroff, made at a news conference here today, have attracted widespread criticism from scientists who have warned that embryonic stem cell technology is not mature enough for applications in humans. Health secretary Prasanna Hota, chief guest at the conference, said his presence should not be construed as an endorsement of the work. “But sometimes, scientific knowledge cannot wait for bureaucratic apparatus,” Hota said. However, reacting to claims by Shroff, scientists have said the absence of regulatory oversight allows virtually unfettered research by the private sector in India. “It looks like anyone can do anything in medical research,” said Satish Totey, director of stem cell research at Manipal Hospital in Bangalore. “Is this the message India wants to give to the world?” One concern among scientists is that embryonic stem cell may carry the risk of tumours. Shroff has asserted that she has not broken any law. “We’re not doing anything unethical. If the ICMR tells us to stop, we will stop,” she said. Top ICMR officials said they had written to Shroff that her work did not have their approval. Existing guidelines on medical ethics make it mandatory for doctors to seek approval from the Indian Council of Medical Research for such research, but there is nothing it can do when private doctors flout guidelines. “Guidelines are only guidelines. Any violations cannot be punished,” said Dorairajan Balasubramanian, research director at the LV Prasad Eye Institute in Hyderabad, himself involved in the use of stem cell to treat eye diseases. The ICMR and the Department of Biotechnology are working to tighten stem cell research rules, but researchers believe progress has been slow. “They should have acted five years ago,” said Totey. Shroff, who got MP Ajit Jogi and other patients to talk about their experiences with her therapy at the conference, said she has informed the ICMR. But ICMR officials said Shroff had only sent details of her patients. “We don’t need patient information for approval process. We have asked for protocols ? things like patient selection criteria, the source of the embryonic stem cell, the method of injecting them and the dosage,” they said. Some stem cell researchers fear a regulatory backlash. “The rules may now become so tight that we’ll find it hard to work,” Totey said. While the ICMR has drafted legislation to make medical ethics mandatory for all, a senior official said it was hard to predict when it would come into effect. It has been cleared by the law ministry and is awaiting cabinet approval,” said Vasantha Muthuswamy, the head of basic medical sciences at the ICMR.
  • 54. International Campaign for Cures of Spinal Cord Injury Paralysis (ICCP) Member Organizations:
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  • 56. ICMR Guidelines for Clinical Research
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  • 62. Medical Director Indian Spinal Injuries Centre Chief of Spine Service &