Question and Answer with Avi Treves PhD from the Sheba Cancer Research Center
Q: What is translational research?
A: Translational research is the research and development work required to develop a technology or potential product from the research laboratory into clinical study. It includes development of production process, quality control assays, upscale of production, regulatory compliance and up to submission package to regulatory agency for approval of a clinical study.
Q: How does a person know what kind of stem cell therapy is best for the disease they have? Umbilical cord stem cells have been recommended for my condition, but I'm afraid that they could cause cancer in me after doing some research. But then again, I also read that some patients with leukemia that were given a bone marrow transplant had strokes after treatment and some had neurological problems after treatment which I already have and don't want any more problems in my brain. It would be good if you could explain expanding the cells after extraction as I've read that expanding them can cause cancer and it is best to inject them straight back in the same day. One company extracts the stem cells from the bone marrow and injects them back the same day via lumbar puncture. Another takes a week to inject them back in. Putting them back in on the same day sounds better as they would be fresh then and not sitting in a lab. I need help understanding all of this.
A: Choosing the right cells for defined clinical condition is still an open question. Most of the products and technologies are still in clinical studies for various indications of regenerative medicine. The only approved protocol is bone marrow transplantation, for replacing ablated bone marrow as part of treatment of hematological malignancies. Thus, to get a treatment for neurological conditions, you need to find the hospital which is conducting clinical studies for your condition, and consult with the doctor there. There are several clinics using cell therapy without US or EU regulatory approval, but most of them did not publish data on their clinical experience. You can search for more information on clinical relevant stem cell therapy, according to key words, in www.mynewtherapy.com.
Q: There seems to be so much research going on with few clinical trials or treatments available. I have a terminal disease and am dismayed that the only place I can get treated is far away from my home in a foreign country. It seems like there is no cooperation when it comes to research either. Each group or university seems to do their own thing. People are suffering and getting tired of endless research on rodents. I would appreciate your comments on the situation.
A: There are numerous clinical studies ongoing in hospitals in the US and EU, using stem cell technologies. You can search for relevant studies or medical centers according to key words in www.clinicaltrials.gov or in a new website dedicated to clinical relevant regenerative technologies http:www.mynewtherapy.com.
Q: Who sets the criteria for clinical trials? It seems like some of the exclusions mean that only the healthiest patients get treated.
A: The criteria for a clinical trial is usually set by the principal investigator. Exclusion criteria indeed narrow down the eligible patients.
Q: Are there treatment centers in Israel for patients that want stem cell therapy? Israel seems to be a hotbed of research, but I have not heard of any clinics there.
A: There are few clinical studies using stem cells ongoing in Israel. There are also some Israeli companies which conduct clinical studies in other countries. You can search for relevant studies or medical centers according to key words (e.g. Israel) in a new website dedicated to clinical relevant regenerative medicine and technologies www.mynewtherapy.com.
Q: I have COPD. My diffusion tests show that I am 29% of predicted. Can stem cell treatment stop the decline in diffusion?
A: There have been in the US two clinical studies with stem cells for COPD, but are presently not recruiting patients. You can search for relevant studies or medical centers according to key words (e.g. COPD) in a new website dedicated to clinical relevant regenerative medicine and technologies http://www.mynewtherapy.com
Q:Can you tell us about some of your most exciting research projects at the moment? Is there anything on the horizon that will change how stem cell therapies are currently done?
A: Stem cell therapy is to my judgment the most exciting and promising approach which will revolutionize medicine. However, it all depends on how you define the "horizon", namely, how long it will take. Developing new treatments and medicines may take decades.
Thanks for asking about my current research. I'm presently working on clinical applications of mesenchymal stem cells, as well as on a new technology to recover therapeutic regenerative cells from peripheral blood. In the cell therapy area, I'm involved in a very promising study for adoptive immunotherapy of metastatic melanoma patients. See our recent publication:
Clinical responses in a phase II study using adoptive transfer of short-term cultured tumor infiltration lymphocytes in metastatic melanoma patients.Besser MJ, Shapira-Frommer R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz L, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J.Clin Cancer Res. 2010 May 1;16(9):2646-55. Or link to:http://www.ncbi.nlm.nih.gov/pubmed/20406835
Q: If a person was pre-cancerous and did not know that or had cancer that was in remission, is stem cell therapy dangerous for them?
A: I'm not sure there is a good answer to this question, there is not enough experience and reported data.
There are some risks in the myeloablation procedure which precede the bone marrow transplant, since it's also immunosuppressive. However, other procedures for stem cells treatments do not require myeloablation.
Q: Is there anything new that you are aware of that is producing results for ALS?
A: Several clinical studies have been done and others are ongoing for treatment of ALS using stem cells. You can search for relevant studies or medical centers according to key words (e.g. ALS) in a new website dedicated to clinical relevant regenerative medicine and technologies www.mynewtherapy.com.
About Avi Treves PhD
Avi Treves PhD
Sheba Cancer Research Center
Tel: +972-52-6666706
Contact: avi.treves@gmail.com
http://il.linkedin.com/in/avitreves
Main Expertise:
1.Besser MJ, Shapira R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz l, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J.
Clinical Responses in a Phase II Study Using Adoptive Transfer of Short-Term Cultured Tumor Infiltration Lymphocytes in Metastatic Melanoma Patients Clinical Cancer Research 2010 1;16(9):2646-55 http://www.ncbi.nlm.nih.gov/pubmed/20406835
2.Pluristem Therapeutics, Cryobanks International, Hospira Inc.
3.ImClone Systems, Bio Rad Europe, Immunovative Therapies.
Q: What is translational research?
A: Translational research is the research and development work required to develop a technology or potential product from the research laboratory into clinical study. It includes development of production process, quality control assays, upscale of production, regulatory compliance and up to submission package to regulatory agency for approval of a clinical study.
Q: How does a person know what kind of stem cell therapy is best for the disease they have? Umbilical cord stem cells have been recommended for my condition, but I'm afraid that they could cause cancer in me after doing some research. But then again, I also read that some patients with leukemia that were given a bone marrow transplant had strokes after treatment and some had neurological problems after treatment which I already have and don't want any more problems in my brain. It would be good if you could explain expanding the cells after extraction as I've read that expanding them can cause cancer and it is best to inject them straight back in the same day. One company extracts the stem cells from the bone marrow and injects them back the same day via lumbar puncture. Another takes a week to inject them back in. Putting them back in on the same day sounds better as they would be fresh then and not sitting in a lab. I need help understanding all of this.
A: Choosing the right cells for defined clinical condition is still an open question. Most of the products and technologies are still in clinical studies for various indications of regenerative medicine. The only approved protocol is bone marrow transplantation, for replacing ablated bone marrow as part of treatment of hematological malignancies. Thus, to get a treatment for neurological conditions, you need to find the hospital which is conducting clinical studies for your condition, and consult with the doctor there. There are several clinics using cell therapy without US or EU regulatory approval, but most of them did not publish data on their clinical experience. You can search for more information on clinical relevant stem cell therapy, according to key words, in www.mynewtherapy.com.
Q: There seems to be so much research going on with few clinical trials or treatments available. I have a terminal disease and am dismayed that the only place I can get treated is far away from my home in a foreign country. It seems like there is no cooperation when it comes to research either. Each group or university seems to do their own thing. People are suffering and getting tired of endless research on rodents. I would appreciate your comments on the situation.
A: There are numerous clinical studies ongoing in hospitals in the US and EU, using stem cell technologies. You can search for relevant studies or medical centers according to key words in www.clinicaltrials.gov or in a new website dedicated to clinical relevant regenerative technologies http:www.mynewtherapy.com.
Q: Who sets the criteria for clinical trials? It seems like some of the exclusions mean that only the healthiest patients get treated.
A: The criteria for a clinical trial is usually set by the principal investigator. Exclusion criteria indeed narrow down the eligible patients.
Q: Are there treatment centers in Israel for patients that want stem cell therapy? Israel seems to be a hotbed of research, but I have not heard of any clinics there.
A: There are few clinical studies using stem cells ongoing in Israel. There are also some Israeli companies which conduct clinical studies in other countries. You can search for relevant studies or medical centers according to key words (e.g. Israel) in a new website dedicated to clinical relevant regenerative medicine and technologies www.mynewtherapy.com.
Q: I have COPD. My diffusion tests show that I am 29% of predicted. Can stem cell treatment stop the decline in diffusion?
A: There have been in the US two clinical studies with stem cells for COPD, but are presently not recruiting patients. You can search for relevant studies or medical centers according to key words (e.g. COPD) in a new website dedicated to clinical relevant regenerative medicine and technologies http://www.mynewtherapy.com
Q:Can you tell us about some of your most exciting research projects at the moment? Is there anything on the horizon that will change how stem cell therapies are currently done?
A: Stem cell therapy is to my judgment the most exciting and promising approach which will revolutionize medicine. However, it all depends on how you define the "horizon", namely, how long it will take. Developing new treatments and medicines may take decades.
Thanks for asking about my current research. I'm presently working on clinical applications of mesenchymal stem cells, as well as on a new technology to recover therapeutic regenerative cells from peripheral blood. In the cell therapy area, I'm involved in a very promising study for adoptive immunotherapy of metastatic melanoma patients. See our recent publication:
Clinical responses in a phase II study using adoptive transfer of short-term cultured tumor infiltration lymphocytes in metastatic melanoma patients.Besser MJ, Shapira-Frommer R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz L, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J.Clin Cancer Res. 2010 May 1;16(9):2646-55. Or link to:http://www.ncbi.nlm.nih.gov/pubmed/20406835
Q: If a person was pre-cancerous and did not know that or had cancer that was in remission, is stem cell therapy dangerous for them?
A: I'm not sure there is a good answer to this question, there is not enough experience and reported data.
There are some risks in the myeloablation procedure which precede the bone marrow transplant, since it's also immunosuppressive. However, other procedures for stem cells treatments do not require myeloablation.
Q: Is there anything new that you are aware of that is producing results for ALS?
A: Several clinical studies have been done and others are ongoing for treatment of ALS using stem cells. You can search for relevant studies or medical centers according to key words (e.g. ALS) in a new website dedicated to clinical relevant regenerative medicine and technologies www.mynewtherapy.com.
About Avi Treves PhD
Avi Treves PhD
Sheba Cancer Research Center
Tel: +972-52-6666706
Contact: avi.treves@gmail.com
http://il.linkedin.com/in/avitreves
Main Expertise:
- Cell therapies and technologies
- Cancer immunotherapy
- Translational research in stem cells and regenerative medicine
- Currently the Deputy Director of the Cancer Research Center at the Sheba Medical Center, Israel. Operating the Ella Institute for Treatment and Research of Melanoma, the Family Cord Blood Bank and Bio Regenerate Inc, a start up company developing adult stem cells technologies and storage services.
- Leading research and development programs for medical applications of adult stem cells from various sources such as peripheral blood, bone marrow and cord blood. Program goals are to treat degenerative diseases such as cardiovascular ischemia, diabetic leg and retinal diseases.
- Co-investigator in the adoptive immunotherapy program of melanoma, - a cell based therapy program in its clinical phase1. Operating a GTP laboratory for cell therapies. Development and production of cell based products in good tissue culture practice (GTP) facility.
- Expert in translational research, regulation and developing cell based technologies, products and their clinical applications. Adviser and scientific board member for biotech companies2. Co-author of more than 90 scientific publications and 10 patents.
- Previously, the founder and CEO of Gamida Cell Ltd.; CEO of Hadasit Ltd., the tech transfer company of the Hadassah Medical Center; Head of the R&D Division of the Hadassah Medical Center and adviser for biotech companies3.
- Gamida Cell Ltd. is now in phase III clinical study of its first product, based on ex vivo expanded hematopoietic stem cells, for bone marrow transplantation.
- PhD from the Weizmann Institute of Science, Israel; Post doc at Stanford University Medical School, CA USA.
1.Besser MJ, Shapira R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz l, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J.
Clinical Responses in a Phase II Study Using Adoptive Transfer of Short-Term Cultured Tumor Infiltration Lymphocytes in Metastatic Melanoma Patients Clinical Cancer Research 2010 1;16(9):2646-55 http://www.ncbi.nlm.nih.gov/pubmed/20406835
2.Pluristem Therapeutics, Cryobanks International, Hospira Inc.
3.ImClone Systems, Bio Rad Europe, Immunovative Therapies.