About Kristin Comella
Kristin Comella has over 15 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development, and senior management. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer. Bioheart is a publically traded company focusing on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Ms. Comella was appointed as Bioheart’s Vice President of R&D and Corporate Development in December 2008. Since joining Bioheart in September 2004, she has played a major role in managing the product development, manufacturing and quality systems. In addition, Ms. Comella is currently and actively serving on multiple boards in the stem cell arena. She is co-founder and Chief Executive Officer of Stemlogix, LLC and Chief Scientific Officer of the Ageless Regenerative Institute. The Ageless and Stemlogix Programs involve education, training, technology and support in delivering regenerative medicine to clinicians and veterinarians. Ms. Comella has years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
Kristin Comella
Chief Scientific Officer
Ageless Regenerative Institute
Tel: (855) 274 -2355
Cell: (813) 390-9874
Fax: (480) 772-4151
email: kcomella@agelessregen.com
web: www.agelessregen.com
Q & A with Bioheart, Inc
Q: Is the angel trial for congestive heart failure that BioHeart is doing with RMI in Mexico underway? If so, do you have anything to report as far as improvements in patients?
A: We have completed enrollment for the phase I Angel Trial. Three month data should be available in under 2 months.
Q: Do you work with anything other than adipose derived stem cells? If not, is there a reason that you have chosen to use adipose derived stem cell exclusively?
A: Bioheart works with Muscle Derived Stem Cells (myoblasts) and adipose derived stem cells. Myoblasts are a uni-potential cell that is only able to form muscle. The cells are injected directly into the scar tissue of congestive heart failure patients with the hope of forming strips of new muscle. We have completed a variety of different trials including most recently part 1 of a phase II/III trial in the US. In this study, patients who received the cells walked almost 100 meters further than patients who received control. This is published in the American Heart Journal: http://www.ncbi.nlm.nih.gov/pubmed/21982657 . The adipose derived cells are currently being utilized in trials for chronic ischemia and the hope is that the cells will form new blood vessels to improve heart functionality. In this case, we target periphery regions as opposed to deep scar. The cells may cause angiogenesis and as a result improve heart function.
Q: I have erectile dysfunction. I found a doctor who administers PRP therapy for it and I want to get this therapy from him, but he said something bizarre that prevents me from seeing him. He is reputable in stem cell research. He helped regenerate a fully functioning rabbit penis in his experiments using stem cells. The strange thing he said however was that stem cell clinics that administer autologous stem cell treatment don't use stem cells, they use stromal cells instead. It is weird that he said this because I've talked to two very good doctors who treat patients with autologous stem cells, they don't use anything but stem cells. His statement is preventing me from seeing him because I perceive it as a dent into his credibility. Can you comment on this?
A: The sample of cells obtained from fat tissue is referred to as a stromal vascular fraction. This is not a pure population of stem cells but instead a mixture of different types of cells including mesenchymal type stem cells, progenitor cells, pericytes, fibroblasts, and more. Autologous means that the samples come from the same patient but this does not have anything to do with the type of cells. So technically the physician is correct in saying that it is stromal cells but a percentage of the stromal cells is stem cells.
Q: I have allergies and chronic perennial rhinitis and following surgeries my upper airways have been ruined so much so that I am unable to work or socialize. This has been going on for 11 years or more.I have joined an online group called "Empty Nose" and have joined a helminthic therapy group where I have self infected myself with 110 hookworms for allergies, but without success.
Members of the Empty Nose are currently having stem cell and PRP injections directly to the nose by doctors in Italy and the U.S., but these have just started and it is difficult to assess as many people have different symptoms and different areas of damage.
I found an interesting article by some researchers at Pusan University who injected adipose stem cells into mice and their allergic airways saw improvements. I contacted them and they said they were a long way from treating humans. I know vets are using stem cells for allergies, etc. on pets.
I don't have funds to just take a chance and am scared of ending up worse than I am. Do you have experience treating anyone with similar circumstances?
A: Please keep in mind that I am not a physician so I can’t provide any specific medical advice. I am aware of several physicians who have had some success using stem cells for autoimmune issues including allergies. Stem cells are anti-inflammatory and immunosuppressant. Based on this theory, the cells could help to suppress an over-reactive immune system that is causing dysfunction. This is still considered experimental and not the standard of care.
Q: Is BioHeart conducting any clinical trials in the U.S. or are these all done in Mexico in partnership with Regenerative Medicine Institute?
A: Bioheart has completed many clinical studies including a US Phase I, US Phase II/III (part 1), EU Phase I, EU phase I/II, and EU phase II. We currently have the MARVEL trial approved by the FDA which is part 2 of a Phase II/III in the US. In addition to these studies, we conduct trials in Mexico with RMI.
Q: When treating a patient who has multiple conditions (for instance lung and heart) how is that done? Would it be separate treatments or is one treatment given in the hopes that a person's overall condition will improve? I am confused as to how the stem cells get to where they need to go.
A: This is protocol specific. In some cases, there may be inclusion/exclusion criteria which would prevent the person from entering a study. The study would be specific to one indication and as long as the other condition does not prevent enrollment, the patient could proceed with treatment. US protocols tend to be very strict and so enrollment for patients with multiple conditions is limited. Often times, studies outside the US have less restrictions. Stem cells have a homing mechanism that makes them travel to areas of inflammation. The cytokines associated with an injury naturally call circulating stem cells to the area to help promote healing.
Q: Is there any proof that adult stem cell treatments have anti-aging effects? I have seen articles claiming that skin can be rejuvenated, so would routine treatment also benefit other organs such as the heart, liver, kidneys, lungs, etc.? Can stem cells restore hair color?
A: At this point, this would be considered experimental and double blind placebo controlled studies have not been completed to demonstrate the anti-aging effects. There have been anecdotal results reported. There have also been reports of stem cells used in hair restoration but I have not seen anything published in color restoration yet.
Q: I noticed on your website that BioHeart now offers stem cell storage for patients who are enrolled in studies in Jamaica and Mexico. Are the stem cells stored in these countries or are they stored in the U.S. and then shipped to the countries where the studies take place? My only thought is that I would worry that my cells could get lost or damaged if they are stored in one country and had to be sent to another country. How long can they be safely stored? This is all so new to me that these are probably stupid questions, but I am curious.
A: Bioheart has a registered tissue bank in Sunrise, Florida. We are able to cryopreserve the cells in liquid nitrogen for years. If a patient is eligible for a treatment, the cells can be sent overnight and preserved in a protectant. The protectant is similar to the solution that organs are sent in when transported for transplant. This preserves the quality and potency of the cells.
Q: Are you doing any clinical studies for CP or do you have any plans to?
A: Bioheart focuses on cardiac indications. The Regenerative Medicine Institute has many IRB (institutional review board) approved studies. One of these includes a protocol for cerebral palsy.
Q: How many patients are considered enough for a proper clinical trial?
A: The number of patients in a study varies depending on the clinical phase. For example, phase I studies are typically smaller studies (20-50 patients) that focus on safety. Phase II and III studies are larger (100-2000 patients) that focus on safety and efficacy. These studies are often double blind placebo controlled and may include different doses.
Q: How long do you usually follow patients before publishing results?
A: Patients are typically followed in a study for 6-12 months. Additional data may be collected for longer periods of time including survival or hospitalizations.
Q: Do patients who participate get any type of discount for treatment or does insurance help pay for any part of the cost?
A: This depends on the specific study. For example, most Bioheart studies are fully sponsored meaning that all treatments and hospital costs are paid by Bioheart. The most recent Angel trial in collaboration with the Regenerative Medicine Institute (RMI) was fully sponsored by Bioheart and the patient is not responsible for any costs. There are other studies that are sponsored by the patients meaning that the patient is responsible for hospital costs but not the investigational product. Some of the IRB studies that are on-going with RMI are patient sponsored studies. Insurance does not typically cover treatments outside the US.
Q: I have many issues such as blurry vision, ED, sleep apnea, headache in the eye and some nerve damage. They were all caused by a medication that was forced upon me. Is it possible to inject a continuous stream of stem cells throughout the body so that all those issues are treated in one shot?
A: It is important to discuss your specific case with your physician to determine if regenerative medicine may be an option for you. Stem cells do have a natural homing mechanism associated with them. They tend to home to areas of injury so it is theoretically possible that stem cells delivered intravenously could provide benefit for multiple issues. Keep in mind that this is still considered experimental and that many studies are under way to fully understand the mechanisms of action.
Kristin Comella has over 15 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development, and senior management. Ms. Comella has been a member of the Bioheart Inc. senior management team since 2004 and is currently serving as the Chief Scientific Officer. Bioheart is a publically traded company focusing on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Ms. Comella was appointed as Bioheart’s Vice President of R&D and Corporate Development in December 2008. Since joining Bioheart in September 2004, she has played a major role in managing the product development, manufacturing and quality systems. In addition, Ms. Comella is currently and actively serving on multiple boards in the stem cell arena. She is co-founder and Chief Executive Officer of Stemlogix, LLC and Chief Scientific Officer of the Ageless Regenerative Institute. The Ageless and Stemlogix Programs involve education, training, technology and support in delivering regenerative medicine to clinicians and veterinarians. Ms. Comella has years of cell culturing experience including building and managing the stem cell laboratory at Tulane University's Center for Gene Therapy. She also developed stem cell therapies for osteoarthritis at Osiris Therapeutics. Ms. Comella holds an M.S. in Chemical Engineering from The Ohio State University and a B.S. in Chemical Engineering from the University of South Florida.
Kristin Comella
Chief Scientific Officer
Ageless Regenerative Institute
Tel: (855) 274 -2355
Cell: (813) 390-9874
Fax: (480) 772-4151
email: kcomella@agelessregen.com
web: www.agelessregen.com
Q & A with Bioheart, Inc
Q: Is the angel trial for congestive heart failure that BioHeart is doing with RMI in Mexico underway? If so, do you have anything to report as far as improvements in patients?
A: We have completed enrollment for the phase I Angel Trial. Three month data should be available in under 2 months.
Q: Do you work with anything other than adipose derived stem cells? If not, is there a reason that you have chosen to use adipose derived stem cell exclusively?
A: Bioheart works with Muscle Derived Stem Cells (myoblasts) and adipose derived stem cells. Myoblasts are a uni-potential cell that is only able to form muscle. The cells are injected directly into the scar tissue of congestive heart failure patients with the hope of forming strips of new muscle. We have completed a variety of different trials including most recently part 1 of a phase II/III trial in the US. In this study, patients who received the cells walked almost 100 meters further than patients who received control. This is published in the American Heart Journal: http://www.ncbi.nlm.nih.gov/pubmed/21982657 . The adipose derived cells are currently being utilized in trials for chronic ischemia and the hope is that the cells will form new blood vessels to improve heart functionality. In this case, we target periphery regions as opposed to deep scar. The cells may cause angiogenesis and as a result improve heart function.
Q: I have erectile dysfunction. I found a doctor who administers PRP therapy for it and I want to get this therapy from him, but he said something bizarre that prevents me from seeing him. He is reputable in stem cell research. He helped regenerate a fully functioning rabbit penis in his experiments using stem cells. The strange thing he said however was that stem cell clinics that administer autologous stem cell treatment don't use stem cells, they use stromal cells instead. It is weird that he said this because I've talked to two very good doctors who treat patients with autologous stem cells, they don't use anything but stem cells. His statement is preventing me from seeing him because I perceive it as a dent into his credibility. Can you comment on this?
A: The sample of cells obtained from fat tissue is referred to as a stromal vascular fraction. This is not a pure population of stem cells but instead a mixture of different types of cells including mesenchymal type stem cells, progenitor cells, pericytes, fibroblasts, and more. Autologous means that the samples come from the same patient but this does not have anything to do with the type of cells. So technically the physician is correct in saying that it is stromal cells but a percentage of the stromal cells is stem cells.
Q: I have allergies and chronic perennial rhinitis and following surgeries my upper airways have been ruined so much so that I am unable to work or socialize. This has been going on for 11 years or more.I have joined an online group called "Empty Nose" and have joined a helminthic therapy group where I have self infected myself with 110 hookworms for allergies, but without success.
Members of the Empty Nose are currently having stem cell and PRP injections directly to the nose by doctors in Italy and the U.S., but these have just started and it is difficult to assess as many people have different symptoms and different areas of damage.
I found an interesting article by some researchers at Pusan University who injected adipose stem cells into mice and their allergic airways saw improvements. I contacted them and they said they were a long way from treating humans. I know vets are using stem cells for allergies, etc. on pets.
I don't have funds to just take a chance and am scared of ending up worse than I am. Do you have experience treating anyone with similar circumstances?
A: Please keep in mind that I am not a physician so I can’t provide any specific medical advice. I am aware of several physicians who have had some success using stem cells for autoimmune issues including allergies. Stem cells are anti-inflammatory and immunosuppressant. Based on this theory, the cells could help to suppress an over-reactive immune system that is causing dysfunction. This is still considered experimental and not the standard of care.
Q: Is BioHeart conducting any clinical trials in the U.S. or are these all done in Mexico in partnership with Regenerative Medicine Institute?
A: Bioheart has completed many clinical studies including a US Phase I, US Phase II/III (part 1), EU Phase I, EU phase I/II, and EU phase II. We currently have the MARVEL trial approved by the FDA which is part 2 of a Phase II/III in the US. In addition to these studies, we conduct trials in Mexico with RMI.
Q: When treating a patient who has multiple conditions (for instance lung and heart) how is that done? Would it be separate treatments or is one treatment given in the hopes that a person's overall condition will improve? I am confused as to how the stem cells get to where they need to go.
A: This is protocol specific. In some cases, there may be inclusion/exclusion criteria which would prevent the person from entering a study. The study would be specific to one indication and as long as the other condition does not prevent enrollment, the patient could proceed with treatment. US protocols tend to be very strict and so enrollment for patients with multiple conditions is limited. Often times, studies outside the US have less restrictions. Stem cells have a homing mechanism that makes them travel to areas of inflammation. The cytokines associated with an injury naturally call circulating stem cells to the area to help promote healing.
Q: Is there any proof that adult stem cell treatments have anti-aging effects? I have seen articles claiming that skin can be rejuvenated, so would routine treatment also benefit other organs such as the heart, liver, kidneys, lungs, etc.? Can stem cells restore hair color?
A: At this point, this would be considered experimental and double blind placebo controlled studies have not been completed to demonstrate the anti-aging effects. There have been anecdotal results reported. There have also been reports of stem cells used in hair restoration but I have not seen anything published in color restoration yet.
Q: I noticed on your website that BioHeart now offers stem cell storage for patients who are enrolled in studies in Jamaica and Mexico. Are the stem cells stored in these countries or are they stored in the U.S. and then shipped to the countries where the studies take place? My only thought is that I would worry that my cells could get lost or damaged if they are stored in one country and had to be sent to another country. How long can they be safely stored? This is all so new to me that these are probably stupid questions, but I am curious.
A: Bioheart has a registered tissue bank in Sunrise, Florida. We are able to cryopreserve the cells in liquid nitrogen for years. If a patient is eligible for a treatment, the cells can be sent overnight and preserved in a protectant. The protectant is similar to the solution that organs are sent in when transported for transplant. This preserves the quality and potency of the cells.
Q: Are you doing any clinical studies for CP or do you have any plans to?
A: Bioheart focuses on cardiac indications. The Regenerative Medicine Institute has many IRB (institutional review board) approved studies. One of these includes a protocol for cerebral palsy.
Q: How many patients are considered enough for a proper clinical trial?
A: The number of patients in a study varies depending on the clinical phase. For example, phase I studies are typically smaller studies (20-50 patients) that focus on safety. Phase II and III studies are larger (100-2000 patients) that focus on safety and efficacy. These studies are often double blind placebo controlled and may include different doses.
Q: How long do you usually follow patients before publishing results?
A: Patients are typically followed in a study for 6-12 months. Additional data may be collected for longer periods of time including survival or hospitalizations.
Q: Do patients who participate get any type of discount for treatment or does insurance help pay for any part of the cost?
A: This depends on the specific study. For example, most Bioheart studies are fully sponsored meaning that all treatments and hospital costs are paid by Bioheart. The most recent Angel trial in collaboration with the Regenerative Medicine Institute (RMI) was fully sponsored by Bioheart and the patient is not responsible for any costs. There are other studies that are sponsored by the patients meaning that the patient is responsible for hospital costs but not the investigational product. Some of the IRB studies that are on-going with RMI are patient sponsored studies. Insurance does not typically cover treatments outside the US.
Q: I have many issues such as blurry vision, ED, sleep apnea, headache in the eye and some nerve damage. They were all caused by a medication that was forced upon me. Is it possible to inject a continuous stream of stem cells throughout the body so that all those issues are treated in one shot?
A: It is important to discuss your specific case with your physician to determine if regenerative medicine may be an option for you. Stem cells do have a natural homing mechanism associated with them. They tend to home to areas of injury so it is theoretically possible that stem cells delivered intravenously could provide benefit for multiple issues. Keep in mind that this is still considered experimental and that many studies are under way to fully understand the mechanisms of action.