Brief Answer:
Stem cell treatments for peripheral neuropathy not approved by FDA

Detailed Answer:
Good evening and thank you for your question.

I looked at the web site of the UNIVERSE company offering stem cell therapy for peripheral neuropathy. There is no significant amount of information on this site for me to judge whether or not what they are offering has merit or likely to work based on any scientific data. In fact, the site has no specifics that I could see as to the evidence for their therapies or whether or not they are FDA approved.

The fact is, that as of XXXXXXX 13, 2019 the FDA has only approved stem cells derived from cord blood or bone marrow to treat cancers of the blood. There are no therapies at this time which have been FDA approved for the treatment of PERIPHERAL NEUROPATHY. This does not mean that TRIALS or CLINICAL EXPERIMENTS have not been approved but that is different from actual THERAPIES which are being promoted for the specific treatment of a human ailment.

There are literally HUNDREDS of clinics all over the United States and abroad claiming the use of stem cells to treat numerous ailments, however, most have been unproven through approved clinical trials that have been accepted by the medical community as being bona fide forms of therapies. The vast majority of these types of clinics promote their products on the basis of anecdotal reports from "satisfied or cured patients" or there are quotes from medical professionals (usually those who work at the company) that a particular treatment is "known" to work...though they do not reveal by means they know this to be true.

The vast majority of insurance companies including MEDICARE do not reimburse for such services since they are considered experimental and do not have any backing by the FDA. Treatments can be as expensive as $25,000 and do not guarantee any degree of success. There are also a list of potential side effects that are quite significant and in some cases severely disabling or even lethal and therefore, for someone such as yourself who has gotten to the age of 71 with a genetic neuropathy extending to the shins I believe the potential risks far away the benefits of this style of treatments which the FDA still considers highly experimental.

Please refer to this link which is the most recent CONSUMERS CAUTION statement on stem cell therapies:

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

The following link is an article recently published highlighting the dangers of stem cell clinics in general and how the FDA is working to shut down unapproved treatments and therapies: https://www.vox.com/2019/1/9/0000/stem-cell-therapy-fda

You should also understand that in order to receive injections of stem cells a person has to undergo a phase of PROCESSING whereby their bone marrow is IRRADIATED or CHEMICALLY INTOXICATED so as to eliminate all potential for the marrow to produce blood cells and other elements that can interfere with the function and integration of stem cells into the body. This means that patients can develop a number of complications including severe infections, bleeding complications requiring transfusions, and respiratory system complications.

Here is a PARTIAL list of side effects that commonly are reported as a result of STEM CELL THERAPY:

Mouth and throat pain
Mucositis
Nausea and vomiting
Infection
Bleeding and transfusions
Interstitial pneumonitis and other lung problems
Graft-versus-host disease
Hepatic veno-occlusive disease (VOD)
Graft failure

I believe that the risks of stem cell therapies (except those currently approved by the FDA- which do NOT include treatments for peripheral neuropathy) are significant and likely outweigh the benefits in any particular patient. This is not to say that stem cell therapies for peripheral neuropathy may not in fact be BENEFICIAL and offer good alternatives to current standards of care which involve mostly medications to reduce intensity of symptoms. In your case, numbness is not a symptom that has any medication that specifically treats it or reverts you to having sensation because you know that hasn't happened to date.

I would not recommend this therapy to any of my patients based upon what I know of the State of the Art at this time as well as the fact that FDA approval is likely still years away for any academic institution let alone private company.

If you are still interested in a particular company's services then, I highly recommend you check into the company further by calling the FDA at: 888-463-6332 to ask what if any approvals exist on file for stem cells to treat PERIPHERAL NEUROPATHY. You should also ask if the company has applied or been approved for any Investigational New Drug Application (IND) or such communications have occurred between the company and the FDA before making any commitments to be treated.

If you have an interest in participating in a CLINICAL TRIAL through a private based company such as UNIVERSE then, make sure you ask to see the FDA approval certificate for the trial being proposed as well as the IND Number and dates of validation for the study to enroll patients and to run. If the company cannot or refuses to produce such documentation then, it's a safe bet that the FDA is not involved in the process and I would advise you seriously reconsider any relationship with them.

If I've provided useful or helpful information to your question and you have no further inquiries or comments at this time then, could you do me the utmost of favors in CLOSING THE QUERY along with a few POSITIVE WORDS of feedback and maybe even a 5 STAR rating if you feel it is deserving? I am definitely interested in getting updated information on how things are going in the next few days or weeks if you'd drop me a line at www.bit.ly/drdariushsaghafi

You can always reach me at the above address for this and other questions. I wish you the best with everything and hope this conversation has helped you give you a little more direction as to what you may wish to do as well as things you can discuss with your doctors or any company you are considering for stem cell treatment.

This query required 55 minutes of professional time to research, assimilate, and respond in complete form.

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Brief Answer:
Stem cell treatments for peripheral neuropathy not approved by FDA

Detailed Answer:
Good evening and thank you for your question.

I looked at the web site of the UNIVERSE company offering stem cell therapy for peripheral neuropathy. There is no significant amount of information on this site for me to judge whether or not what they are offering has merit or likely to work based on any scientific data. In fact, the site has no specifics that I could see as to the evidence for their therapies or whether or not they are FDA approved.

The fact is, that as of XXXXXXX 13, 2019 the FDA has only approved stem cells derived from cord blood or bone marrow to treat cancers of the blood. There are no therapies at this time which have been FDA approved for the treatment of PERIPHERAL NEUROPATHY. This does not mean that TRIALS or CLINICAL EXPERIMENTS have not been approved but that is different from actual THERAPIES which are being promoted for the specific treatment of a human ailment.

There are literally HUNDREDS of clinics all over the United States and abroad claiming the use of stem cells to treat numerous ailments, however, most have been unproven through approved clinical trials that have been accepted by the medical community as being bona fide forms of therapies. The vast majority of these types of clinics promote their products on the basis of anecdotal reports from "satisfied or cured patients" or there are quotes from medical professionals (usually those who work at the company) that a particular treatment is "known" to work...though they do not reveal by means they know this to be true.

The vast majority of insurance companies including MEDICARE do not reimburse for such services since they are considered experimental and do not have any backing by the FDA. Treatments can be as expensive as $25,000 and do not guarantee any degree of success. There are also a list of potential side effects that are quite significant and in some cases severely disabling or even lethal and therefore, for someone such as yourself who has gotten to the age of 71 with a genetic neuropathy extending to the shins I believe the potential risks far away the benefits of this style of treatments which the FDA still considers highly experimental.

Please refer to this link which is the most recent CONSUMERS CAUTION statement on stem cell therapies:

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

The following link is an article recently published highlighting the dangers of stem cell clinics in general and how the FDA is working to shut down unapproved treatments and therapies: https://www.vox.com/2019/1/9/0000/stem-cell-therapy-fda

You should also understand that in order to receive injections of stem cells a person has to undergo a phase of PROCESSING whereby their bone marrow is IRRADIATED or CHEMICALLY INTOXICATED so as to eliminate all potential for the marrow to produce blood cells and other elements that can interfere with the function and integration of stem cells into the body. This means that patients can develop a number of complications including severe infections, bleeding complications requiring transfusions, and respiratory system complications.

Here is a PARTIAL list of side effects that commonly are reported as a result of STEM CELL THERAPY:

Mouth and throat pain
Mucositis
Nausea and vomiting
Infection
Bleeding and transfusions
Interstitial pneumonitis and other lung problems
Graft-versus-host disease
Hepatic veno-occlusive disease (VOD)
Graft failure

I believe that the risks of stem cell therapies (except those currently approved by the FDA- which do NOT include treatments for peripheral neuropathy) are significant and likely outweigh the benefits in any particular patient. This is not to say that stem cell therapies for peripheral neuropathy may not in fact be BENEFICIAL and offer good alternatives to current standards of care which involve mostly medications to reduce intensity of symptoms. In your case, numbness is not a symptom that has any medication that specifically treats it or reverts you to having sensation because you know that hasn't happened to date.

I would not recommend this therapy to any of my patients based upon what I know of the State of the Art at this time as well as the fact that FDA approval is likely still years away for any academic institution let alone private company.

If you are still interested in a particular company's services then, I highly recommend you check into the company further by calling the FDA at: 888-463-6332 to ask what if any approvals exist on file for stem cells to treat PERIPHERAL NEUROPATHY. You should also ask if the company has applied or been approved for any Investigational New Drug Application (IND) or such communications have occurred between the company and the FDA before making any commitments to be treated.

If you have an interest in participating in a CLINICAL TRIAL through a private based company such as UNIVERSE then, make sure you ask to see the FDA approval certificate for the trial being proposed as well as the IND Number and dates of validation for the study to enroll patients and to run. If the company cannot or refuses to produce such documentation then, it's a safe bet that the FDA is not involved in the process and I would advise you seriously reconsider any relationship with them.

If I've provided useful or helpful information to your question and you have no further inquiries or comments at this time then, could you do me the utmost of favors in CLOSING THE QUERY along with a few POSITIVE WORDS of feedback and maybe even a 5 STAR rating if you feel it is deserving? I am definitely interested in getting updated information on how things are going in the next few days or weeks if you'd drop me a line at www.bit.ly/drdariushsaghafi

You can always reach me at the above address for this and other questions. I wish you the best with everything and hope this conversation has helped you give you a little more direction as to what you may wish to do as well as things you can discuss with your doctors or any company you are considering for stem cell treatment.

This query required 55 minutes of professional time to research, assimilate, and respond in complete form.

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