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Regenerative Medicine for Brain Injury
Free Download: Stem Cell Therapy for Traumatic Brain Injury
Disclaimer:
The information provided by R3 Stem Cell is for educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Individual results may vary and are not guaranteed. The FDA considers stem cell therapy experimental at this point.
Any claims made on this website refer to procedures performed OUTSIDE of the USA. R3 Stem Cell has clinics in Mexico, Philippines, South Africa, Turkey, India, Pakistan.
Every day, R3 Stem Cell receives inquiries worldwide from individuals asking if stem cell therapy can help with Traumatic Injury (TBI). Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells work for TBI, the latest research, and what to expect with a regenerative procedure.
Traumatic brain injury (TBI) is a leading cause of death and disability, with a high burden on patients, their families, and society. Long-term mortality in TBI is substantial, and TBI survivors have a life expectancy shortened by 6 years.
Of all types of injury, those to the brain are among the most likely to result in death or permanent disability. Brain injury is the leading cause of death and disability worldwide. Every day, 153 people in the United States die from injuries that include TBI.
Motor Vehicle Crashes account for 50% of all TBIs. This includes autos, trucks, motorcycles, bicycles, and pedestrians hit by vehicles. The leading causes of TBI vary by age: falls are the leading cause of TBI among persons aged 65 years and older; transportation is the leading cause of TBI among persons under the age of 65 years. Estimates suggest that sports related brain injury accounts for close to 300,000 injuries each year.
TBI results in neuroinflammation, cortical degeneration, white matter damage, neuronal loss, and blood–brain barrier (BBB) dysfunction. As a consequence, approximately 30% of patients experience the development of progressive neurological deficits.
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Treatment of TBI patients has not changed much in the last 20 years, consisting only of supportive therapy directed at prevention, early detection and treatment of second insults. Neuroprotective treatments are urgently needed for this condition.
With improving medical technology, the survival rate of patients with TBI has increased significantly. After emergent treatment with neurosurgical decompression, craniotomy and shunts if necessary, patients often face a long road ahead. Various types of disabilities result, such as body motor dysfunction, language and communication difficulties, mental problems, along with psychological and cognitive defects.
After surgical treatments are completed, symptomatic treatments ensue with PT, OT and medications as needed for issues like spasms, seizures, etc.
As you will see from the studies below, there is a better option for TBI patients than to just receive symptomatic treatments. While not all TBI patients will respond dramatically to stem cell treatment, the vast majority experience noticeable quality of life improvements. Especially with a treatment regimen of multiple injections.
He was conscious but did not respond, tetraplegic with high-degree muscle spasms, and could not speak, control his sphincter or communicate. He completed almost a year in a rehabilitation clinic but did not show much progress. Injections of botulinum toxin against muscle spasms provided only partial relief. His upper extremities were hyperflexed in a decorticated pose, and his lower extremities stretched. His muscle tone was improved, and everyday tasks such as mobilization and bathing became considerably difficult. At this point, the patient was referred for the MSC trial. The patient received six rounds of treatment with umbilical cord mesenchymal stem cells over a period of six months (one month apart). Each treatment consisted of a combination of 1 million stem cells per kilogram applied the follows:
The participant endured the process excellently and did not have any serious injection related side effects.
He had only early, temporary complications such as subfebrile fever, moderate headache, and muscle pain related to intramuscular injection, which were settled by symptomatic medical care within 24-48 hours.
The participant demonstrated changes in his speech, mental skills, ability to focus, concentration, short-term memory and fine and gross motor movements in our present case report. His degree of autonomy increased, as demonstrated by the one-year follow-up improvement of his Functional Independence Measure motor scale score from 13/91 at baseline to 46/91. His cognitive score progress was much higher than his motor score, improving from 9/35 at baseline to 27/35 on the third-month follow-up. His cognitive score was 30/35 at the last follow-up.
A Korean group performed a pilot trial in 2013, where 3 severe TBI patients were treated with intravascular umbilical cord blood (UCB) therapy twice with non-myeloablative immunosuppression and concomitant EPO injection.
Three patients with severe TBI received two UCB therapies each. Severe TBI was defined as a Glasgow Coma Scale (GCS) score of 8 or less, or loss of consciousness (LOC) for more than 1 day.
All patients received comprehensive and inpatient-based rehabilitation continuously.
The minimum number of UCB cells, as total nucleated cells (NCs), was twenty-five million per kilogram.
Because a single cord blood unit did not contain sufficient numbers of nucleated cells, multiple UCB units were infused in each patient. Before infusion, UCB units were washed to remove dimethyl sulfoxide. The UCB was administered through intravenous or intra-arterial routes. For patient 1, she was unable to stand alone due to right side weakness and could not walk even with a one-man assist before the first UCB therapy. She had a short attention span and low cognition, along with global aphasia and her aphasia quotient (AQ) was 0. She tried to grab anyone with her left hand and bite anything in her hands. She was 19 years old at the time of her car accident, and received umbilical cord stem cell therapy starting at 3 years, 10 months post-accident.
Regarding her status at 14 months after the second administration, she became able to control herself and understand simple verbal commands, and attentive activities appeared. She became able to stand from a sitting position by herself while holding a handle on the wall and to walk for approximately 50m with minimal-to-moderate assistance by one therapist.
Patient 2 was 32 years old and also sustained a severe TBI from a car accident. He could not control his head, turn his body, or maintain a sitting posture due to poor trunk control. Language evaluation showed Broca’s aphasia and his AQ was 12.8 (8th percentile).
On an activities of daily living (ADL) evaluation, he was totally dependent. He constantly showed impulsive and aggressive behaviors. He could not sit alone or stand, even with maximal assistance from a therapist.
At 4 years post injury, he received 46 million nucleated cells per kilogram IV and then 8 months later received cord blood again with 32 million nucleated cells per kilogram. After the second UCB therapy, spasticity decreased from grade 2 to grade 1, He began to maintain table sitting for a few seconds without assistance and sit from the decubitus position using his right upper extremity. Approximately 17 months after the second UCB therapy, he was able to swallow a honey-like and nectar-like dysphagia diet without aspiration in a swallowing study.
Patient 3 was 20 years old and injured in a car accident. A brain MRI taken at 11 months post-injury showed extensive encephalomalacia with brain atrophy. At 7 months after the accident, he received 27 million nucleated cells/kilogram and then again 5 months later with 38 million NC/kg. The vegetative status was not changed by UCB Therapy. Spasticity improved, though.
In 2013, Wang et all recruited forty patients with sequelae of TBI and randomly assigned them to either the stem cell treatment group or the control group. The patients in the stem cell treatment group underwent 4 stem cell transplantations via lumbar puncture. Ten million stem cells were slowly injected intrathecal 4 times over a period of 5-7 days.
The two groups showed equivalent baseline scores, indicating they were comparable.
At the 6-month follow-up, the stem cell group showed significant improvements with motor, sensation and balance scores in both upper and lower extremities. In addition, the stem cell group showed significant improvements in the self-care sub-score, mobility sub-score, locomotion sub-score and communication sub-score.
All in all, the study results confirmed that the umbilical cord mesenchymal stem cell transplantation improved the neurological function and self-care in patients with TBI sequelae
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R3 is used to perform autologous therapies, where a patient’s own bone marrow or adipose stem cells are used. However, a lot of stem cells in one’s body are as old as that person is, and hence not very active. Their ability to successfully increase sufficient blood flow and allow for tissue regeneration is inferior to umbilical cord stem cells.
Specifically, the therapeutic potential of autologous bone marrow or adipose stem cells in the treatment of older patients is impaired by a number of age-related factors such as oxidative stress, telomere length, DNA damage, disease, and long-term use of some medications.
This is in stark contrast to the youthful genotype and phenotype of neonatal tissue-derived stem cells, such as from the umbilical cord. They are better at facilitating repair and regeneration of tissue damage, creating new blood flow with superior anti-inflammatory and immunomodulatory efficacy compared to mature stem cells from one’s adipose or bone marrow.
As a result of the inferiority of autologous stem cells due to the reasons above and better results being seen with umbilical cord stem cells, R3 only uses the donor stem cells today.
Stem cells and exosomes act in the body through several mechanisms. They do NOT become part of a patient’s DNA, which means they do not engraft into the person’s existing cells. The predominant method of action is thought to be through paracrine mechanisms, which means “cell to cell” interaction.
They act through:
Stem Cells can also release a huge variety of molecules into the extracellular environment. These molecules, which include extracellular vesicles, lipids, free nucleic acids, and soluble proteins, exert crucial roles in repairing damaged tissue.
Along with offering MSCs for the treatment of Traumatic Brain Injury, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell-to-cell communication for new blood flow creation.
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Where do the stem cells and exosomes come from?
R3 Stem Cell’s regenerative biologics originate from umbilical cord tissue that has been donated after a scheduled c-section. No baby (or mother) is harmed during the C-section procedure. The umbilical cord tissue is normally discarded, but if the mother passes screening tests, then the umbilical cord is immediately sent to the lab. The screening tests are extremely rigorous and mandated by the USA FDA.
The lab carefully processes the umbilical cord to generate large amounts of stem cells and exosomes that are of the highest quality possible. The lab team consists of multiple PhD’s working in ISO Certified, cGMP compliant clean rooms to ensure quality assurance that exceeds USA FDA standards. The proprietary production process combines the highest potency, safety and affordability for providers to confidently offer exosome procedures.
Millions of dollars have been invested in the pharmaceutical grade production of the biologics, including first rate clean rooms, bioreactors, nano-particle tracking analyzers, cytometers, PCR, tangential flow machines and real-time environmental monitoring. The quality assurance testing complies with screening and testing stan¬dards consistent with the American Association of Tissue Banks, cGMP standards, FDA regulations and the highest level of any regulatory agency globally.
Stem Cell-Derived Exosomes
R3 Stem Cell’s Centers of Excellence globally include umbilical cord stem cell derived exosomes with umbilical cord stem cells to provide enhanced results. Exosomes are lipid bound vesicles (acellular) produced by cells that contain a plethora of growth factors, cytokines, mRNA and other proteins.
They are exceptionally helpful in cell-to-cell communication and very effective for reducing inflammation when they become ingested by their recipient cell. They act as shuttles to send nucleic acids and proteins to other cells, in this way, allowing cell-to-cell communication and transporting molecules among both close and distant cells. In general, these released proteins are important regulators of intracellular information.
Exosomes could be the mediators of many stem cell-associated therapeutic activities. We have seen them to be “faster acting” than stem cells, so R3 frequently uses them in conjunction to provide a “1-2 punch” for patient outcomes.
Is stem cell therapy safe?
After a decade of performing over 24,000 stem cell procedures worldwide, R3 knows that the regenerative procedures are safe. The quality control employed during the stem cell production is second to none, and the side effects R3 sees are usually mild to moderate and temporary.
They may include itching, dizziness, lightheadedness, low grade fever, chills, headache, and nausea. These are typically temporary. If a patient has an allergic reaction to the multivitamin or a preservative, all of R3’s Centers have the medications to resolve it quickly.
One of the questions we get asked a lot is, “Will the stem cells get rejected?” The answer is NO.
MSCs do not express major histocompatibility complex (MHC) antigens of the class II subtype and contain low levels of MHC molecules of the class I subtype. MSCs also lack the co-stimulatory molecules essential for immune detection, including CD40, CD80, and CD86.
Therefore, MSCs generally have low immunogenicity and can avoid immune rejection by the recipient, which serves as the foundation for their successful application without needing to match the donor to the recipient. Scientists call this being “immunologically privileged”.
Another question often asked is, “Is there a chance of a tumor forming?” Current research has concluded that the answer is NO. The mesenchymal stem cells and exosomes used during treatment have never been shown to have tumor forming potential. In fact, they have been shown to be anti-tumor forming
For the past decade, R3 has been successfully treating Traumatic Brain Injury with stem cell and exosome procedures. The regenerative biologics are applied directly into the spinal cord with an intrathecal application, and also infused through an IV. Typically, more than one session is required for optimal benefit. This was shown in the studies described in this Guide, where better outcomes were associated with multiple procedures.
R3’s providers use one to two million stem cells per kilogram, to make sure that patients achieve the absolute best outcome possible. Between 50 and 150 billion exosomes are included in each procedure.
Similar to the research mentioned above, R3 Stem Cell’s outcomes for TBI have been exceptional! The patient satisfaction rate is 75% year over year for RBI. Patients typically experience symptomatic improvement in sitting/ standing balance, bed mobility, trunk stability, upper limb function, mobility, sensation, bowel/bladder functions, and activities of daily living. Keep in mind that results cannot be guaranteed and will vary between individuals.
It may take a few months to see the improvements, as it can take that long to build up new blood flow and create neurological repair.
Because stem cell therapy for TBI is not a permanent cure, it’s important to make it affordable. Repeat therapies can help maintenance and/or achieve additional improvements for pain relief. So a lot of patients seek additional treatments at R3 Stem Cell every twelve to eighteen months.
R3 Stem Cell’s fees are less than half what comparable (and reputable) regenerative clinics charge. Be wary of clinics trying to pass off PRP as a stem cell therapy. If they mention only taking your blood for the treatment, it is NOT a stem cell treatment!
R3’s Experience
For the past decade, R3 Stem Cell’s Centers globally have performed over 24,000 regenerative procedures in six countries. Several hundred have been for SCI. Patient satisfaction across all conditions treated is 85%!
R3 combines safety, effectiveness and affordability for the therapies. Internationally, the Intellicell is used, which is culturing the most active mesenchymal stem cells to create the“smartest” stem cell in the world!
R3 Stem Cell offers free consultations for individuals to discuss whether regenerative therapy is indicated for their AS. Simply call +1 (844) GET-STEM or +1 (888) 988-0515 to schedule yours!
Disclaimer: This guide’s education does not constitute medical advice. The USA FDA considers stem cell therapy experimental. Any claims made in this Guide refer to procedures performed outside of the USA.
References
David Greene, MD, PhD, MBA, Founder/CEO
R3 Stem Cell offers treatments that bring patients hope and options. Hope that surgery can be avoided, and tissue injury can be repaired, with patients being able to get back to desired activities.
Founder and CEO David Greene, MD, PhD, MBA writes extensively on regenerative medicine and gives many seminars worldwide on a regular basis. With over forty Centers of Excellence globally, R3 is at the forefront of regenerative therapies.
R3’s Centers have successfully performed over 25,000 regenerative procedures to date. Call today for your free consultation (844) GET-STEM!
No portion of this Document may be reproduced without the Express Written Consent of R3 Stem Cell.
Disclaimer: This guide’s education does not constitute medical advice. The USA FDA considers stem cell therapy experimental. Any claims made in the Guide refer to procedures performed outside the USA.
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The information provided by R3 Stem Cell is not a substitute for professional medical advice, diagnosis, or treatment. Individual results may vary and only your medical professional can explain all the risks and potential benefits of any therapy based on your circumstances. R3 Stem Cell does not recommend or endorse any specific tests, products, procedures, opinions, or other information that may be mentioned on this website. Reliance on any information provided by R3 Stem Cell, its employees, others appearing on this website at the invitation of R3 Stem Cell, or other visitors to the website is solely at your own risk. R3 Stem Cell is not responsible for the outcome of your procedure. The FDA considers stem cell therapy experimental at this point.
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