Dr. Javier Lopez, Regenerative Medicine Institute MX was invited to host Ask the Doctor this month to address specific questions concerning a patient's complaint that has been posted on the internet and to explain the protocol his clinic uses to inform patients about treatment and track their results. RMI is a multi-specialty group of Board Certified physicians and allied health professionals. RMI is located in Tijuana, Mexico. RMI has completed the ICMS accreditation program. We want to thank Dr. Lopez for addressing these issues for our members.
Q:Taking into consideration that the person who posted negative information on the internet about your clinic and Angeles Hospital is not something anyone can really verify, how have you responded to this person? In other words, what is your side of the story?
A: We are very concerned about our patients' well being and address their concerns in the most serious manner. While it’s the stories of success that make this clinical trial exciting, there will occasionally be disappointments that we must learn from.
We pride ourselves on the fact that we respond to all patient inquires and will stop at nothing to provide a safe environment for patients to be treated and a supportive environment for them to recover. It’s important that we work as a team, bringing in the best specialists, and following up with patients after they return home.
That said, when patients enroll in our clinical trial we must follow specific protocol – protocol we cannot deviate from without putting our entire study at risk. Although it would be natural to want to make exceptions for an unhappy patient, we are only able to do so within the time constraints dictated by protocol. These fixed practices are set in place so that we can fairly gauge how stem cells impact each condition.
In the case of the patient referred to in the question, we are very sorry that we were unable to comply with her requests, since doing so would imply a deviation from protocol, which would put the protocol and the program in jeopardy.
We were in contact with the patient, returning her calls, sometimes leaving messages when she was not up to talking, as well as responding to all e-mails, and made a genuine effort to facilitate her situation and to offer the possibility of trying to pursue a higher level of improvement after her 12 month follow-up period had expired, an offer which she refused.
Unfortunately the patient didn’t take into account, that by not approaching the issue in a responsible manner, she may jeopardize other patient’s chances of receiving some benefit from these trials.
In our effort to be transparent, the following appears on our web site:
http://www.regenerativemedicine.mx/ and http://www.regenerativemedicine.mx/download.html
The forms found on the website are in addition to the myriad of other consents we ask each patient to sign, including one that reads:
I understand that Regenerative Medicine Institute, Mexico does not claim to cure or guarantee an improvement in anyone’s condition to anyone undergoing stem cell treatment.
I understand that each patient is unique and no particular result or outcome can be predicted or guaranteed.
We want every patient to be happy that they have taken part in our trial and work hard to make that happen.
Q: How many patients have you treated for COPD and how many have stayed improved after 12 months? I realize you have been promising results for over a year, but I still haven't seen any.
A: So far we’ve treated 24 patients for COPD. They haven’t all hit the 12-month mark, however, we are currently analyzing the data for those who have and will be making preliminary results available shortly.
Note from moderator concerning results that were posted previously on this forum.
http://www.stemcellpioneers.com/showthread.php?t=5294
Q: What's the purpose of having someone who is not a citizen of the country where they get treatment sign an Informed Consent? Wouldn't it be hard to sue a doctor for malpractice or for not letting a patient know something was experimental if they didn't live in that country?
A: Giving our patients the information they need up-front in order to make an informed decision as to whether they would like to take part in our clinical trial is an ethical issue for us. We don’t want there to be any misunderstandings during what is likely a stressful time in a patient’s life. We spell things out in a clear and concise manner so that a patient and his/her family can be confident about the decision they’re making. Also, it is protocol to obtain informed consent for any experimental therapy. We at RMI run trials according to current FDA clinical practices. This means that informed consent must be obtained before a patient can continue in the study. We do not make promises for outcomes and make it clear that these treatments are still considered experimental.
It is also worth noting that we must adhere to state and federal regulations in Mexico, and the governing body for healthcare COFEPRIS, which requires that all patients sign informed consents in order to receive treatment of any kind within Mexico.
Even if informed consent was not required by protocol, it would be the right thing to do.
Q: What procedures do you use to follow up with patients? If there is a death post treatment, how many months after treatment would this seem relevant for you to know and investigate if that's what you do?
A: The outcome of each patient’s case is important to us, both in terms of our clinical trial and our natural desire to see each patient improve. We spend time with these people and we care about the outcome of their treatment. Protocol dictates a strict set of parameters regarding follow-up, but even if those parameters weren’t in place, we would want to know how each patient is doing. Protocol involves monitoring patients for six months, or in some cases, a full year. This means that we periodically collect information regarding a patient’s condition, including any adverse events. It’s just as important to know about set-backs as it is to know about successes because they will ultimately help us hone in on what works best. In the case of a severe adverse event, such as death, an independent monitoring board would become involved. This board works to determine whether the death can in any way be attributed to the experimental therapy or if it is the result of another cause. Patients are protected by the fact that the monitoring board has the power to discontinue the trial at any time.
Q: A press release back in April stated that RMI would present a summary of clinical data at the annual ISSCR meeting. There are some ISSCR members who have not been very favorable to offshore clinics. Some research scientists in fact, have been quite bold in stating that patients should not take risks by getting stem cell therapy other than with treatments that are FDA approved or by participating in FDA approved clinical trials. Is the ISSCR by inviting you to present your summary stating that what you are doing is as good as an FDA approved clinical trial? Did you have to pay the ISSCR to be a presenter?
A: The review team at ISSCR found our data important enough to allow for presentation at the conference. We did not pay ISSCR to present.
Q: Do you have research scientists that work for you? I am just wondering how you get your protocols that are used to treat the various diseases that you treat.
A: Our protocols are developed by a group of physicians and research scientists, which are integral parts of our team, but are also shaped through collaboration with universities and biotech companies in the US and in Mexico. Such collaboration is an important part of what we do as it helps us ensure patient safety.
Q: When a patient contacts you, are you careful to point out that the treatment may not help them at all? The internet attack almost sounded as if the person had been led to believe that they would get positive results. I don't see how anyone could predict that even with approved medicines and treatments, but I also think that trying to sell a patient on at least trying treatment is a common practice at a lot of clinics.
A:Our patients tend to be savvy and do a great deal of research prior to joining RMI’s clinical trial. We turn away patients we believe we cannot help and inform all others that stem cell therapies are considered experimental. All patients are required to sign an informed consent, which clearly states risks and the experimental nature of the trial. No one benefits if patients go into the trial without this important information.
Q: Is there a reason that a company like BioHeart would collaborate with an offshore clinic rather than go through the FDA approval process in the U.S.? Does it get them in the door in the U.S. or is it too expensive or what are the reasons?
A: Bioheart made the decision to collaborate with Regenerative Medicine Institute, Mexico for a variety of reasons. The trials in the US are extremely expensive and the inclusion/exclusion criteria for patients can be limiting. Because of the strict parameters currently adhered to by the FDA many patients simply do not qualify for US trials. By choosing to work with a reputable offshore program, Bioheart knows that more patients will have the opportunity to seek alternative therapies, putting the decision back into the hands of patients.
Q: How do you answer criticism of offshore clinics by research scientists and the media? There seems to be a lot of articles critical of offshore clinics. On one PhD's blog recently he seemed to gloat about the negative information posted on the internet against your clinic.
A: We are not blind to the offshore clinics that have failed to approach stem cell trials with the same level of control and safety as RMI or who have entered the field simply to make money. It is, at best, frustrating for us when all trials are lumped together – the good with the terrible. Because our energy cannot be diverted from patient care to fighting rumors, we must accept this unfortunate truth as a hazard of being on the forefront of stem cell research. We at RMI have had many successful cases and wonderful outcomes, but as with any medical therapy there are going to patients who are less satisfied with their outcome. As physicians who have sworn to do no harm, it is difficult when a patient is dissatisfied, but again, we must focus on the prize – extending our understanding through research.
In keeping with our commitment to be as transparent as possible, we are more than open to receiving any qualified professionals who care to tour our facility and evaluate the standard of care given therein. This includes a thorough review of our protocols and the submission and approval process for each of these.
Even though we are a Mexican institution who must submit to Mexican health regulations, we run all of our trials according to FDA clinical practice guidelines. Visitors are more than welcome to review that fact.
Partial information on our protocols can be found on clinicaltrials.gov, a service of the NIH.
http://clinicaltrials.gov/ct2/results?term=stem+cells+tijuana
Q: If you have a complaint adjudication process, how does that work? The negative posts on the internet make it sound like there has been no response and therefore they had to take their complaints to the internet. How many months of follow up do you do with patients?
A: We do have an adverse event adjudication process that kicks in any time there is a complaint. As members of ICMS, an independent data safety monitoring board reviews all complaints to determine if it is due to the trial or if it has another genesis. The board has the authority to recommend discontinuation of the trial in the event that it is found to be unsafe. Again, due to strict protocols put in place to protect the sanctity of the study, we are unable to offer patients more stem cells before the follow up period of time has passed.
All patients treated in our facility are registered with ICMS, and included in their database.
All patients that believe that there has been an oversight in their care may and should contact ICMS.
Additional comments:
Throughout the entirety of our process we seek two things, to prove that the use of adult autologous stem cells is both safe and effective. Safety and efficacy being our main focus, we still take great pleasure in the successes of our patients and strive to improve so that they can be repeated with patients to follow. It’s been noted that many of our patients show both an improvement in quality of life and clinical parameters, a small percentage see no change at all and continue to deteriorate, and another group will see a halt to the progression of their disease. We believe the latter to be the case of the patient who chose to express her grievances through social media. From what we’ve gathered from her claims, in her own words she has stated that her lab results have showed that she has stayed exactly the same in the 10 months since her treatment, something which is usually unheard of in that type of liver disease. So while she may not have received the cure she was hoping for (and one she was never promised), we believe that not deteriorating is a positive outcome in any condition, especially chronic degenerative diseases.
Q:Taking into consideration that the person who posted negative information on the internet about your clinic and Angeles Hospital is not something anyone can really verify, how have you responded to this person? In other words, what is your side of the story?
A: We are very concerned about our patients' well being and address their concerns in the most serious manner. While it’s the stories of success that make this clinical trial exciting, there will occasionally be disappointments that we must learn from.
We pride ourselves on the fact that we respond to all patient inquires and will stop at nothing to provide a safe environment for patients to be treated and a supportive environment for them to recover. It’s important that we work as a team, bringing in the best specialists, and following up with patients after they return home.
That said, when patients enroll in our clinical trial we must follow specific protocol – protocol we cannot deviate from without putting our entire study at risk. Although it would be natural to want to make exceptions for an unhappy patient, we are only able to do so within the time constraints dictated by protocol. These fixed practices are set in place so that we can fairly gauge how stem cells impact each condition.
In the case of the patient referred to in the question, we are very sorry that we were unable to comply with her requests, since doing so would imply a deviation from protocol, which would put the protocol and the program in jeopardy.
We were in contact with the patient, returning her calls, sometimes leaving messages when she was not up to talking, as well as responding to all e-mails, and made a genuine effort to facilitate her situation and to offer the possibility of trying to pursue a higher level of improvement after her 12 month follow-up period had expired, an offer which she refused.
Unfortunately the patient didn’t take into account, that by not approaching the issue in a responsible manner, she may jeopardize other patient’s chances of receiving some benefit from these trials.
In our effort to be transparent, the following appears on our web site:
http://www.regenerativemedicine.mx/ and http://www.regenerativemedicine.mx/download.html
The forms found on the website are in addition to the myriad of other consents we ask each patient to sign, including one that reads:
I understand that Regenerative Medicine Institute, Mexico does not claim to cure or guarantee an improvement in anyone’s condition to anyone undergoing stem cell treatment.
I understand that each patient is unique and no particular result or outcome can be predicted or guaranteed.
We want every patient to be happy that they have taken part in our trial and work hard to make that happen.
Q: How many patients have you treated for COPD and how many have stayed improved after 12 months? I realize you have been promising results for over a year, but I still haven't seen any.
A: So far we’ve treated 24 patients for COPD. They haven’t all hit the 12-month mark, however, we are currently analyzing the data for those who have and will be making preliminary results available shortly.
Note from moderator concerning results that were posted previously on this forum.
http://www.stemcellpioneers.com/showthread.php?t=5294
Q: What's the purpose of having someone who is not a citizen of the country where they get treatment sign an Informed Consent? Wouldn't it be hard to sue a doctor for malpractice or for not letting a patient know something was experimental if they didn't live in that country?
A: Giving our patients the information they need up-front in order to make an informed decision as to whether they would like to take part in our clinical trial is an ethical issue for us. We don’t want there to be any misunderstandings during what is likely a stressful time in a patient’s life. We spell things out in a clear and concise manner so that a patient and his/her family can be confident about the decision they’re making. Also, it is protocol to obtain informed consent for any experimental therapy. We at RMI run trials according to current FDA clinical practices. This means that informed consent must be obtained before a patient can continue in the study. We do not make promises for outcomes and make it clear that these treatments are still considered experimental.
It is also worth noting that we must adhere to state and federal regulations in Mexico, and the governing body for healthcare COFEPRIS, which requires that all patients sign informed consents in order to receive treatment of any kind within Mexico.
Even if informed consent was not required by protocol, it would be the right thing to do.
Q: What procedures do you use to follow up with patients? If there is a death post treatment, how many months after treatment would this seem relevant for you to know and investigate if that's what you do?
A: The outcome of each patient’s case is important to us, both in terms of our clinical trial and our natural desire to see each patient improve. We spend time with these people and we care about the outcome of their treatment. Protocol dictates a strict set of parameters regarding follow-up, but even if those parameters weren’t in place, we would want to know how each patient is doing. Protocol involves monitoring patients for six months, or in some cases, a full year. This means that we periodically collect information regarding a patient’s condition, including any adverse events. It’s just as important to know about set-backs as it is to know about successes because they will ultimately help us hone in on what works best. In the case of a severe adverse event, such as death, an independent monitoring board would become involved. This board works to determine whether the death can in any way be attributed to the experimental therapy or if it is the result of another cause. Patients are protected by the fact that the monitoring board has the power to discontinue the trial at any time.
Q: A press release back in April stated that RMI would present a summary of clinical data at the annual ISSCR meeting. There are some ISSCR members who have not been very favorable to offshore clinics. Some research scientists in fact, have been quite bold in stating that patients should not take risks by getting stem cell therapy other than with treatments that are FDA approved or by participating in FDA approved clinical trials. Is the ISSCR by inviting you to present your summary stating that what you are doing is as good as an FDA approved clinical trial? Did you have to pay the ISSCR to be a presenter?
A: The review team at ISSCR found our data important enough to allow for presentation at the conference. We did not pay ISSCR to present.
Q: Do you have research scientists that work for you? I am just wondering how you get your protocols that are used to treat the various diseases that you treat.
A: Our protocols are developed by a group of physicians and research scientists, which are integral parts of our team, but are also shaped through collaboration with universities and biotech companies in the US and in Mexico. Such collaboration is an important part of what we do as it helps us ensure patient safety.
Q: When a patient contacts you, are you careful to point out that the treatment may not help them at all? The internet attack almost sounded as if the person had been led to believe that they would get positive results. I don't see how anyone could predict that even with approved medicines and treatments, but I also think that trying to sell a patient on at least trying treatment is a common practice at a lot of clinics.
A:Our patients tend to be savvy and do a great deal of research prior to joining RMI’s clinical trial. We turn away patients we believe we cannot help and inform all others that stem cell therapies are considered experimental. All patients are required to sign an informed consent, which clearly states risks and the experimental nature of the trial. No one benefits if patients go into the trial without this important information.
Q: Is there a reason that a company like BioHeart would collaborate with an offshore clinic rather than go through the FDA approval process in the U.S.? Does it get them in the door in the U.S. or is it too expensive or what are the reasons?
A: Bioheart made the decision to collaborate with Regenerative Medicine Institute, Mexico for a variety of reasons. The trials in the US are extremely expensive and the inclusion/exclusion criteria for patients can be limiting. Because of the strict parameters currently adhered to by the FDA many patients simply do not qualify for US trials. By choosing to work with a reputable offshore program, Bioheart knows that more patients will have the opportunity to seek alternative therapies, putting the decision back into the hands of patients.
Q: How do you answer criticism of offshore clinics by research scientists and the media? There seems to be a lot of articles critical of offshore clinics. On one PhD's blog recently he seemed to gloat about the negative information posted on the internet against your clinic.
A: We are not blind to the offshore clinics that have failed to approach stem cell trials with the same level of control and safety as RMI or who have entered the field simply to make money. It is, at best, frustrating for us when all trials are lumped together – the good with the terrible. Because our energy cannot be diverted from patient care to fighting rumors, we must accept this unfortunate truth as a hazard of being on the forefront of stem cell research. We at RMI have had many successful cases and wonderful outcomes, but as with any medical therapy there are going to patients who are less satisfied with their outcome. As physicians who have sworn to do no harm, it is difficult when a patient is dissatisfied, but again, we must focus on the prize – extending our understanding through research.
In keeping with our commitment to be as transparent as possible, we are more than open to receiving any qualified professionals who care to tour our facility and evaluate the standard of care given therein. This includes a thorough review of our protocols and the submission and approval process for each of these.
Even though we are a Mexican institution who must submit to Mexican health regulations, we run all of our trials according to FDA clinical practice guidelines. Visitors are more than welcome to review that fact.
Partial information on our protocols can be found on clinicaltrials.gov, a service of the NIH.
http://clinicaltrials.gov/ct2/results?term=stem+cells+tijuana
Q: If you have a complaint adjudication process, how does that work? The negative posts on the internet make it sound like there has been no response and therefore they had to take their complaints to the internet. How many months of follow up do you do with patients?
A: We do have an adverse event adjudication process that kicks in any time there is a complaint. As members of ICMS, an independent data safety monitoring board reviews all complaints to determine if it is due to the trial or if it has another genesis. The board has the authority to recommend discontinuation of the trial in the event that it is found to be unsafe. Again, due to strict protocols put in place to protect the sanctity of the study, we are unable to offer patients more stem cells before the follow up period of time has passed.
All patients treated in our facility are registered with ICMS, and included in their database.
All patients that believe that there has been an oversight in their care may and should contact ICMS.
Additional comments:
Throughout the entirety of our process we seek two things, to prove that the use of adult autologous stem cells is both safe and effective. Safety and efficacy being our main focus, we still take great pleasure in the successes of our patients and strive to improve so that they can be repeated with patients to follow. It’s been noted that many of our patients show both an improvement in quality of life and clinical parameters, a small percentage see no change at all and continue to deteriorate, and another group will see a halt to the progression of their disease. We believe the latter to be the case of the patient who chose to express her grievances through social media. From what we’ve gathered from her claims, in her own words she has stated that her lab results have showed that she has stayed exactly the same in the 10 months since her treatment, something which is usually unheard of in that type of liver disease. So while she may not have received the cure she was hoping for (and one she was never promised), we believe that not deteriorating is a positive outcome in any condition, especially chronic degenerative diseases.