I received a written reply to my e-mail request to the NIH yesterday when I asked about why there are no relevant clinical trials at the NIH using stem cells for treating COPD. I am posting the reply in the ICMS section to continue to bring home the message to everyone how badly we need to support ICMS. We just are never going to get beyond the research, research, research stage otherwise for years if you ask me. Here goes -
August 11, 2009
Your letter of July 29, 2009 to the NIH Acting Director was referred to the National Heart, Lung, and Blood Institute (NHLBI) for response since we support research on chronic obstructive pulmonary disease (COPD). Thank you for your letter encouraging research to develop novel approaches for therapy, such as lung tissue regeneration. The NHLBI recognizes the seriousness of COPD and the need for research to develop better treatments for this condition. There are currently 19 open trials on COPD that are listed on http://clinicaltrials.gov, reflecting a strong interest in research by both the NIH and industry.
The NHLBI has recently funded several new research programs on COPD. These include a large study of the genetics of COPD (COPDGene), a clinical research study to characterize molecular abnormalities in COPD (SPIROMICS), and four Speciailized Centers for Clinically Oriented Research (SCCOR) in COPD, which are conducting basic and clinical research to better understand the mechanisms involved in COPD pathogenesis. In addition, the NHLBI continues to support a large trial of supplemental oxygen therapy in patients with COPD (LOTT), several clinical trials that are underway within the COPD Colinical Research Network (CCRN), and a program that collects human lung tissues and makes them available to investigators for use in COPD research (Lung Tissue Research Consortium). The NHLBI also provides research grants to many investigators across the country, enabling their studies of the pathways and mechanisms involved in COPD. We are hopeful that this active and growing program of research will soon lead to new, more effective, methods for treating COPD.
One promising approach for the treatment of COPD is lung regeneration, possibly through the use of stem cells. This field is at an early stage of development, especially for its application to lung diseases. Most of the research performed thus far has used animal models or tissue preparations, and much work must still be done to develop practical treatments and to demonstrate their safety and efficacy in humans. Although ongoing basic stem cell research is potentially relevant to COPD, no studies have yet been published involving patients with COPD. One study, sponsored by Osiris Therapeutics to test the safety of a stem cell treatment, has completed enrollment of subjects, but its results are not yet available (further information is available at: http://www.clinicaltrials.gov/ct2/show/NCT00683722?term=Stem+Cell+COPD&rank=1 We are not aware of any other clinical trials of stem cell therapies that are actively enrolling subjects with COPD at this time.
Although there is no cure, effective treatments are available for COPD, even in its most advanced stages. If you have not already done so, you may wish to seek the advice of a pulmonary specialist at a major medical center, such as the University of Colorado Health Sciences Center (UCHSC), regarding the best way to manage your disease. One expert in pulmonary medicine and COPD at UCHSC, Denver is Dr. Marvin I. Schwarz. He can be contacted at (303)315-7047.
I hope this information is helpful to you. With best regards,
Sincerely,
Elizabeth G. Nabel, M.D.
Director
August 11, 2009
Your letter of July 29, 2009 to the NIH Acting Director was referred to the National Heart, Lung, and Blood Institute (NHLBI) for response since we support research on chronic obstructive pulmonary disease (COPD). Thank you for your letter encouraging research to develop novel approaches for therapy, such as lung tissue regeneration. The NHLBI recognizes the seriousness of COPD and the need for research to develop better treatments for this condition. There are currently 19 open trials on COPD that are listed on http://clinicaltrials.gov, reflecting a strong interest in research by both the NIH and industry.
The NHLBI has recently funded several new research programs on COPD. These include a large study of the genetics of COPD (COPDGene), a clinical research study to characterize molecular abnormalities in COPD (SPIROMICS), and four Speciailized Centers for Clinically Oriented Research (SCCOR) in COPD, which are conducting basic and clinical research to better understand the mechanisms involved in COPD pathogenesis. In addition, the NHLBI continues to support a large trial of supplemental oxygen therapy in patients with COPD (LOTT), several clinical trials that are underway within the COPD Colinical Research Network (CCRN), and a program that collects human lung tissues and makes them available to investigators for use in COPD research (Lung Tissue Research Consortium). The NHLBI also provides research grants to many investigators across the country, enabling their studies of the pathways and mechanisms involved in COPD. We are hopeful that this active and growing program of research will soon lead to new, more effective, methods for treating COPD.
One promising approach for the treatment of COPD is lung regeneration, possibly through the use of stem cells. This field is at an early stage of development, especially for its application to lung diseases. Most of the research performed thus far has used animal models or tissue preparations, and much work must still be done to develop practical treatments and to demonstrate their safety and efficacy in humans. Although ongoing basic stem cell research is potentially relevant to COPD, no studies have yet been published involving patients with COPD. One study, sponsored by Osiris Therapeutics to test the safety of a stem cell treatment, has completed enrollment of subjects, but its results are not yet available (further information is available at: http://www.clinicaltrials.gov/ct2/show/NCT00683722?term=Stem+Cell+COPD&rank=1 We are not aware of any other clinical trials of stem cell therapies that are actively enrolling subjects with COPD at this time.
Although there is no cure, effective treatments are available for COPD, even in its most advanced stages. If you have not already done so, you may wish to seek the advice of a pulmonary specialist at a major medical center, such as the University of Colorado Health Sciences Center (UCHSC), regarding the best way to manage your disease. One expert in pulmonary medicine and COPD at UCHSC, Denver is Dr. Marvin I. Schwarz. He can be contacted at (303)315-7047.
I hope this information is helpful to you. With best regards,
Sincerely,
Elizabeth G. Nabel, M.D.
Director
