Cell Therapy
***Disclaimer: This blog is not meant to be used as legal or medical
advice. It is written as my person perspective on how medical
professionals could blend western medicine with other modalities***
Greetings
and welcome to another episode of the Integrated Pharmacist Podcast.
Today I'd like to talk to you about cell therapy. This modality
involves the injection of healthy cells in order to promote healing in a
sick patient. Western medicine has accepted this method at least to a
small degree. Most people have heard of a bone marrow transplant. This
is an example of cell therapy practiced in western medicine.
In its early days, cell therapy included injecting healthy, mature cells specific to the injured site. For example, a heart patient might get healthy heart cells - this could be from a deceased human donor. The claim is that these cells would be injected and make their way to the heart and help the body rebuild heart cells. They found that the patient's immune system would react too often to the donated cells (as we learned from early organ transplantation procedures). Over time, the use of undeveloped cells like stem and mesenchymal cells became more popular, because these cells don't have the proteins, sugars, and glycoproteins on their surface that signal to the immune system "self" versus "non-self."
Now, cell therapists use stem cells much like a bone marrow transplant. The modern theory is that the stem cells injected into the deficient tissue or organ will help rebuild the tissue just the way our body would. Sometimes it is injected into the blood so the cells will find the right cells to rebuild. Our understanding of how this works is still evolving. It is currently understood that the stem cells do not build new organ cells directly. Instead, these cells help by reducing inflammation and by communicating through paracrine chemicals to the patient's existing cells. The existing cells appear to do the healing and regrowing expected from this treatment.
To perform this therapy, the practitioner must acquire stem cells. Often, they can use the patient's own bone marrow stem cells or adipose cells. These cells are treated in a solution to cause them to develop into the desired direction toward the kind of cells that need healing. However, the process is stopped before it is developed into a mature cell. This is to reduce the likelihood of rejection.
Umbilical cord blood is another source of stem cells. Although these cells are theoretically generic enough for anyone to use, there are still concerns about matching and rejection. Ideally, patients will use cord blood saved from their own birth. Because of the scarcity of this kind of cell, most practitioners use bone marrow or adipose tissue mesenchymal cells. Although they are still precursor cells, studies involving these methods have been varied and contradictory.
In bone marrow transplant, it could potentially be taken from the patient during a relatively healthy time and then re-injected into the patient. Or, a donor with similar blood can donate their bone marrow cells. When the cells are injected into the sick patient, the cells find their way into the bone where they take over the process of developing blood cells for the patient just like their old bone marrow. This practice helps patients affected by serious infection, injury, or chemotherapy.
This modality is used specifically to treat painful joints whether that be due to arthritis, injury, or over-exertion. It is also used for injured tendons, skin, bone, heart, lungs, and adrenals. People use it for hormone imbalances, erectile dysfunction, degenerative diseases, diabetes, and pains of every kind. It is advertised as an alternative to "risky surgery."
This
modality is supported by a few trials I found. The first study I'd
like to address uses stem cells from harvested umbilical cord blood from
children born with cerebral palsy. This is a double-blind,
placebo-controlled cross-over trial. It was originally designed to
accept 120 children from 2 to 6 years old, but due to the slow process
of finding young children with cerebral palsy who had their cord blood
saved, they ended the trail after 63 participants. Although this looks
like a significant set back, it was determined that they could still
potentially reach significant numbers with this trial size. The
children were also rather homogeneous being mostly white, two-year-old
boys. This makes it difficult to extrapolate results to other groups.
However, by having a cross-over trial, each patient could act as their
own comparison. This helps to make the results stronger, because
differences seen in the treatment compared to placebo reflect what is
happening within the same patients. It helps negate any differences
between the study arms that may not have been accounted for. It also
gets around the dilemma of giving one group a potentially life altering
medication and not the other.
There were three legs of the trial. The placebo group got an injection designed to have the same color and smell as the cord blood injection. The second arm received a small dose of cord blood cells, and the third group received a large dose of cord blood cells. One year after the first dose of placebo or cord blood cells, each participant would then receive the opposite. Whether they received the small or large dose of cord blood was determined by the amount originally donated from each child at birth. Trained physicians and therapists measured motor skill and ability, and analyzed changes in MRIs. They were measured before the first dose, 1 year post first dose (which was when they were given the opposite treatment), and then again at the 2 year mark. The children were also monitored throughout the study.
It may be due to the low number of participants that improvements in the small-dose arm were undetectable. Although limited improvements were detected in the small-dose arm, clinically significant differences were found in the large dose subjects in all measured outcomes. The trial conductors learned that not only does this method of therapy work for cerebral palsy, but there is a preferred dose of greater than 20,000,000 cord blood cells. Though potentially under-reported, side effects were minimal.
The second trial I'd like to discuss built upon the use of umbilical cord cells in the treatment of osteoarthritis (which I'll refer to as OA). This is the primary aim of many cell therapy clinics. The trial looked at older patients with mild to moderate OA in a triple-blinded, placebo-controlled study.
It had 3 arms as well. The placebo arm had a standard-of-care
injection of hyaluronic acid at baseline and 6 months, treatment 1
received 1 dose of cord blood stem cells and 1 dose of hyaluronic acid,
and treatment 2 received 2 doses of cord blood stem cells. They used
the same number of cells for the treatment arm as the previous trial I
mentioned. This study had about 9 people per arm which is quite low
even compared to the other trials I've discussed so far. Despite this,
the administrators were able to calculate statistics of safety and
efficacy. According to this trial, the number needed to treat with
umbilical cord cell therapy for OA is 2. That is, for every 2 patients
who receive treatment, 1 will receive benefit of improved joint function
and pain reduction. We should consider the fact that the study
occurred in Chile and has no mention of diversity of patients. This
ratio may only hold true for this specific population - we don't have
enough information to say otherwise. Also, the greatest efficacy was
obtained in the arm that experienced two doses of cell therapy. By the
way results came out, it appears as though multiple injections would be
needed in order to maintain quality results. On the bright side,
efficacy seems to increase with further dosing unlike steroid injections
which tend to decrease in efficacy over time. There were also minimal
and tolerable side effects from this treatment.
Now let's look at the reality of this therapy. In order to receive this kind of therapy, you must go to a health center that specializes in this modality. It is typically not covered under insurance, so it is a cash-only service. The injection therapies that would be involved in the trials I covered today would cost around $5000 each. I'd like to emphasize that the average patient would likely need multiple injections to see lasting results. That alone makes this modality quite prohibitive. Because the evidence is still growing in this direction, it is unadvised that patients seek this therapy. Even in the favorable odds provided by the second trial I mentioned, there's a 50% chance the patient will see no benefit after spending $5000.
For more information and referrals, you can visit the International Clinic of Biological Regeneration at www.icbr.com.
I hope you have enjoyed learning about cell therapy as much as I have. If you enjoyed this podcast and would like to reach out to me with questions, concerns, comments, or suggestions, please email me at integratedpharmacist@gmail.com. You can also read the blog at www.integratedpharmcist. blogspot.com. I have posted references to the trials there. Thank you for listening and please join us next week for another episode of The Integrated Pharmacist Podcast!
References:
Sun JM, Song AW, Case LE, et al. Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial. Stem Cells Transl Med. 2017;6(12):2071–2078. doi:10.1002/sctm.17-0102
Matas J, Orrego M, Amenabar D, et al. Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med. 2019;8(3):215–224. doi:10.1002/sctm.18-0053
In its early days, cell therapy included injecting healthy, mature cells specific to the injured site. For example, a heart patient might get healthy heart cells - this could be from a deceased human donor. The claim is that these cells would be injected and make their way to the heart and help the body rebuild heart cells. They found that the patient's immune system would react too often to the donated cells (as we learned from early organ transplantation procedures). Over time, the use of undeveloped cells like stem and mesenchymal cells became more popular, because these cells don't have the proteins, sugars, and glycoproteins on their surface that signal to the immune system "self" versus "non-self."
Now, cell therapists use stem cells much like a bone marrow transplant. The modern theory is that the stem cells injected into the deficient tissue or organ will help rebuild the tissue just the way our body would. Sometimes it is injected into the blood so the cells will find the right cells to rebuild. Our understanding of how this works is still evolving. It is currently understood that the stem cells do not build new organ cells directly. Instead, these cells help by reducing inflammation and by communicating through paracrine chemicals to the patient's existing cells. The existing cells appear to do the healing and regrowing expected from this treatment.
To perform this therapy, the practitioner must acquire stem cells. Often, they can use the patient's own bone marrow stem cells or adipose cells. These cells are treated in a solution to cause them to develop into the desired direction toward the kind of cells that need healing. However, the process is stopped before it is developed into a mature cell. This is to reduce the likelihood of rejection.
Umbilical cord blood is another source of stem cells. Although these cells are theoretically generic enough for anyone to use, there are still concerns about matching and rejection. Ideally, patients will use cord blood saved from their own birth. Because of the scarcity of this kind of cell, most practitioners use bone marrow or adipose tissue mesenchymal cells. Although they are still precursor cells, studies involving these methods have been varied and contradictory.
In bone marrow transplant, it could potentially be taken from the patient during a relatively healthy time and then re-injected into the patient. Or, a donor with similar blood can donate their bone marrow cells. When the cells are injected into the sick patient, the cells find their way into the bone where they take over the process of developing blood cells for the patient just like their old bone marrow. This practice helps patients affected by serious infection, injury, or chemotherapy.
This modality is used specifically to treat painful joints whether that be due to arthritis, injury, or over-exertion. It is also used for injured tendons, skin, bone, heart, lungs, and adrenals. People use it for hormone imbalances, erectile dysfunction, degenerative diseases, diabetes, and pains of every kind. It is advertised as an alternative to "risky surgery."
There were three legs of the trial. The placebo group got an injection designed to have the same color and smell as the cord blood injection. The second arm received a small dose of cord blood cells, and the third group received a large dose of cord blood cells. One year after the first dose of placebo or cord blood cells, each participant would then receive the opposite. Whether they received the small or large dose of cord blood was determined by the amount originally donated from each child at birth. Trained physicians and therapists measured motor skill and ability, and analyzed changes in MRIs. They were measured before the first dose, 1 year post first dose (which was when they were given the opposite treatment), and then again at the 2 year mark. The children were also monitored throughout the study.
It may be due to the low number of participants that improvements in the small-dose arm were undetectable. Although limited improvements were detected in the small-dose arm, clinically significant differences were found in the large dose subjects in all measured outcomes. The trial conductors learned that not only does this method of therapy work for cerebral palsy, but there is a preferred dose of greater than 20,000,000 cord blood cells. Though potentially under-reported, side effects were minimal.
The second trial I'd like to discuss built upon the use of umbilical cord cells in the treatment of osteoarthritis (which I'll refer to as OA). This is the primary aim of many cell therapy clinics. The trial looked at older patients with mild to moderate OA in a triple-blinded, placebo-controlled study.
Now let's look at the reality of this therapy. In order to receive this kind of therapy, you must go to a health center that specializes in this modality. It is typically not covered under insurance, so it is a cash-only service. The injection therapies that would be involved in the trials I covered today would cost around $5000 each. I'd like to emphasize that the average patient would likely need multiple injections to see lasting results. That alone makes this modality quite prohibitive. Because the evidence is still growing in this direction, it is unadvised that patients seek this therapy. Even in the favorable odds provided by the second trial I mentioned, there's a 50% chance the patient will see no benefit after spending $5000.
For more information and referrals, you can visit the International Clinic of Biological Regeneration at www.icbr.com.
I hope you have enjoyed learning about cell therapy as much as I have. If you enjoyed this podcast and would like to reach out to me with questions, concerns, comments, or suggestions, please email me at integratedpharmacist@gmail.com. You can also read the blog at www.integratedpharmcist. blogspot.com. I have posted references to the trials there. Thank you for listening and please join us next week for another episode of The Integrated Pharmacist Podcast!
References:
Sun JM, Song AW, Case LE, et al. Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial. Stem Cells Transl Med. 2017;6(12):2071–2078. doi:10.1002/sctm.17-0102
Matas J, Orrego M, Amenabar D, et al. Umbilical Cord-Derived Mesenchymal Stromal Cells (MSCs) for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single MSC Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial. Stem Cells Transl Med. 2019;8(3):215–224. doi:10.1002/sctm.18-0053
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