Hope After Spinal Cord Injury—Real Options, Real Results

Free Download: Stem Cell Therapy for Spinal Cord 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.

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Consumer Guide to Stem Cell Treatment for Spinal Cord Injury

Every day, R3 Stem Cell receives inquiries worldwide from individuals asking if stem cell therapy can help with Spinal Cord Injury (SCI).

Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells work for SCI, the latest research, and what to expect with a regenerative procedure.

A Significant Global Issue

Global estimates suggest that in 2021, approximately 15.4 million people were living with SCI. Males are more commonly affected by SCI than females. Reports have indicated that cervical, thoracic, and lumbar spine injuries account for 4.9%, 28.0%, and 65.9% of total thoracolumbar spinal injuries, respectively.

 

Life expectancy in people with SCI strongly correlates with neurological impairment and preventable secondary conditions. People with SCI often die earlier because of health system factors such as insufficient access to or poor quality health services. For people with SCI, the in-hospital mortality rate is nearly three times higher in low- and middle-income countries than in high-income countries.

Spinal cord injury (SCI) often results in lifelong disability, muscle palsy, sensory disturbances, autonomic dysfunction, and neuropathic pain, as well as bowel and bladder incontinence, depending on the SCI severity. There is no effective method that reverses the trauma, partly because of the extremely limited self-regeneration abilities of the spinal cord.

Get expert advice on spinal cord injury care. Dial (844) GET-STEM.

Traditional Treatments for Spinal Cord Injury

Despite current treatment strategies, including surgical decompression and fixation, the injection of neurotrophic factors, anti-inflammatory medications, and physical rehabilitation, satisfactory therapeutic effects remain elusive. Although a steadily accruing body of evidence points to the central nervous system possessing a means for self-repair, this capacity appears quite limited as a sole clinical approach.

 

The complex pathology of SCI may be divided into primary and secondary injury. The primary injury is characteristically induced by mechanical damage and resultant hemorrhage.

Myriad factors contributing to secondary injury include excitatory amino acid toxicity, oxidative damage, inflammation, and autoimmune response. These combined injury mechanisms, leading to glial and neuronal cell death, demyelination, and axonal degeneration, are manifested as a severe impairment in neurological function.

 

Currently, the only approved medication to treat SCI in clinics is a high dose of corticosteroid. Neuroprotective treatment can be performed in acute phases with ganglioside (GM-1), mouse nerve growth factor (NGF), etc. Conventional rehabilitation therapy was the preferred treatment for the convalescence and sequelae-phase spinal cord injury. Occupational therapy, limb massage, functional breathing, and defecation training, etc., can to some extent delay disuse muscle atrophy and retain a portion of limb function.

Stem Cell Therapy for Spinal Cord Injury

Human umbilical cord mesenchymal stem cells (hUC-MSC) are a promising choice for SCI therapy. Their use has many benefits, including in revascularization support, control of inflammation, inhibition of cellular apoptosis, and production of multiple trophic factors, as well as the differentiation of hUC-MSCs into oligodendrocytes and neurons. Moreover, additional advantages, including their lack of contamination, easy obtainability, low immunogenicity, and rapid proliferation, make them a highly suitable candidate for SCI therapy.

 

Of the numerous possible transplantation routes, it has been demonstrated that cell engraftment and tissue sparing are significantly better after intrathecal delivery, and that the host immune response is reduced with subarachnoid infusion. It has also been reported that intrathecal administration of stem cells results in better functional recovery than other approaches of cellular delivery. Whether any engraftment actually occurs with stem cell transplantation is debatable in these situations.

2014 Study Evaluating Umbilical Cord Mesenchymal Stem Cells

A person in a wheelchair holding a tablet, highlighting benefits of stem cell therapy for spinal cord injury.A 2014 study in the Journal of Translational Medicine evaluated umbilical cord mesenchymal stem cells for transplantation and compared neurofunctional outcomes of patients suffering sequelae of thoracolumbar spinal cord injury that were treated with stem cell transplantation, rehabilitation training, or no treatment.

 

34 cases of thoracolumbar spinal cord injury that were graded ‘A’ by the AIS grading system were randomly divided into 3 groups: the stem cell transplantation group, the rehabilitation therapy group, and the blank control group. The stem cell group received 40 million umbilical cord mesenchymal stem cells through intrathecal application on two separate procedures, 10 days apart.

 

Through scaled ratings and urodynamic examinations, this study proved that transplantation of UCMSCs has advantages in neurofunctional recovery in comparison with rehabilitation therapy and self-healing alone. The stem cell transplantation group improved significantly in motor function (P = 0.012); that is, the muscle strength of the waist, abdomen, and lower limbs increased. Seven of the 10 patients had their muscle strength increased from level 0 to level 1 or 2 (data not shown), and motor function of the paralyzed limbs improved as muscle strength increased. The rehabilitation group and blank control group also showed some improvements but the difference was not statistically significant.

 

Regarding muscle tension, excessive muscle tension significantly decreased (P = 0.007) after stem cell transplantation. Eight patients showed excessive muscle tension before treatment, and 7 of them (87.5%) had their muscle tension decreased (data not shown); the rehabilitation group and blank control group showed no significant improvements in muscle tension (P > 0.05).

 

As to self-care ability, the stem cell transplantation group significantly improved in activities such as bed-chair transfer, bowel and urinary retention, and ground movements, which are related to a decrease in excessive muscle tension and an improvement in movement ability of the paralyzed limbs. The rehabilitation group showed some improvements but the differences were not statistically significant (P > 0.05). The self-care ability of the blank control group decreased (P > 0.05), most likely representing functional decline of the limbs due to lack of treatment and use.

 

This study demonstrated that umbilical cord mesenchymal stem cell transplantation is effective in the treatment for sequelae of thoracolumbar spinal cord injury. This method can alleviate lower limb muscle tension, increase limb strength, and improve urinating function. The method’s efficacy is more significant in comparison with rehabilitation therapy, and no adverse effects were found.

Further Studies on Umbilical Cord Mesenchymal Stem Cells

Clinical setting featuring a wheelchair and medical chart, symbolizing advancements in stem cell therapy for spinal cord injuries.

A 2013 study out of China evaluated 22 patients with SCI treated with umbilical cord mesenchymal stem cells via intrathecal injection. The dosage was one million stem cells/kg body weight once a week given four times as a course. Treatment was effective in 13 of 22 patients; nine patients had no response.

 

Among patients with incomplete SCI, the response to treatment was 81.25%; there was no response to treatment among six patients with complete SCI. Five patients with a response to treatment received two to three courses of therapy, and effects in these patients were further enhanced. In most patients in whom treatment was effective, motor or sensory functions, or both, were improved, and bowel and bladder control ability was improved. In 22 patients 1 month after therapy, algesia, tactile sensation, motion and activity of daily living scale were significantly improved.

 

Clinical Trials in Hong Kong and Kunming

Medical professionals analyzing MRI scans during clinical trials, highlighting advancements in spinal cord injury treatments.

In a phase I and II clinical trials in Hong Kong (HK), researchers injected umbilical cord blood into the spinal cords of people with chronic (1–19 years after) complete SCI. In the phase I trial in HK, eight patients received a total of 1.6 or 3.2 million UCB-MNCs transplanted into the spinal cord. None of these patients recovered any motor function.

 

In the phase II trial in Kunming, 20 patients with chronic (average of 7 years after injury) complete C5–T11 SCI were sequentially assigned to five treatment groups of increasing cord blood cell dosing. Over half of the patients recovered walking with minimal or no assistance by 6–12 months after UCB-MNC transplants and locomotor training, as well as increased independence in activities of daily living, including self-care, bowel and bladder management, and mobility. This was an unprecedented recovery for complete chronic SCI.

 

The conclusion was that the data indicated that UCB-MNCs can be safely transplanted into the spinal cords of people with chronic SCI, intensive locomotor training is essential for motor recovery, and UCB-MNC transplants combined with intensive locomotor recovery can lead to significant locomotor, bowel, and bladder recovery in people with chronic complete SCI.

However, the patients did not recover much voluntary motor function. Some patients recovered sensory dermatomes close to the injury site, and as many as a quarter of the patients recovered anal sensation and voluntary sphincter contraction, converting from AIS A to B and C.

2021 Study on Subarachnoid Transplantations

Three medical professionals examining MRI scans, symbolizing research and advancements in subarachnoid stem cell transplantations.

In 2021, a prospective, single-center, single-arm study in which subjects received four subarachnoid transplantations of human umbilical cord mesenchymal stem cells, hUC-MSCs (1 × 10⁶ cells/kg) monthly and were seen in follow-up four times (1, 3, 6, and 12 months after final administration) was conducted and published out of China. A total of 102 participants were treated, and side effects included headache, fever, dizziness, and transient increase in muscle tension. The amount of cells administered equaled 1 million stem cells per kilogram times four treatments.

 

All subjects enrolled in this trial were suffering long-standing and stable neurological dysfunction, and those subjects with SCI in the acute phase were excluded. For the purpose of accurate assessment of the therapeutic efficacy of hUC-MSCs, the authors only recruited subjects whose chronicity of SCI was no less than 2 months. In the authors’ study, it is possibly due to the great severity of injury that some subjects showed no significant recovery of neurological function after hUC-MSC administration.

 

In the authors’ study, the two primary outcomes—IANR-SCIFRS (SCI Functional Rating Scale of the International Association of Neurorestoratology) and ASIA total scores at the final follow-up—showed remarkable improvements when compared with baseline data, indicating the therapeutic efficacy of hUC-MSCs in treating SCI.

 

Subgroup analysis also demonstrated that stem cell therapy could improve neurological dysfunction regardless of injury characteristics, including lesions at the cervical, thoracic, and thoracolumbar levels; complete and incomplete damage; and early and late chronic phases. Perhaps the aforementioned positive results are due to sufficient quantity of transplanted stem cells and long observation period.

 

In addition, in different aspects of neurological disability caused by chronic paraplegia, sensation was found to recover more quickly and significantly than motion and sphincter function after intrathecal transplantation of hUC-MSCs. Moreover, the secondary outcomes, including muscle spasm, autonomic system and bladder and bowel functions, improved remarkably, supporting the application of stem cell therapy in clinic.

 

Regarding other secondary efficacy indicators, early and progressive improvement of muscle spasticity is a beneficial outcome of cytotherapy, and a decrease In residual urine volume can be observed prior to restoration of other neurological functions. Another positive function is eliminating glial scars within damaged spinal cord and thus benefiting regeneration of remyelinated axons. The authors’ present protocol demonstrates that intrathecal administration of allogeneic hUC-MSCs at a dose of one million stem cells per kilogram once a month for 4 months is safe and effective and leads to significant improvement in neurological dysfunction and recovery of quality of life.

2017 Study Evaluating Autologous Bone Marrow MSCs

Four graphs displaying progressive improvements in PPS, LTS, Motor, and Total ASIA scores over time, with error bars indicating variability at each time point. A 2017 study out of Spain evaluated ten patients with established incomplete SCI receiving four subarachnoid administrations of 30 million autologous bone marrow MSCs, supported in autologous plasma, at months 1, 4, 7, and 10 of the study, and were followed until the month 12. Urodynamic, neurophysiological, and neuroimaging studies were performed at months 6 and 12, and compared with basal studies.

 

Variable improvement was found in the patients of the series. All of them showed some degree of improvement in sensitivity and motor function. Sexual function improved in two of the eight male patients. Neuropathic pain was present in four patients before treatment; it disappeared in two of them and decreased in another. Clear improvement in bladder and bowel control were found in all patients suffering previous dysfunction. Urodynamic studies showed variability between patients, but 80% of them showed improvement in bladder compliance, reflecting the improvement in bladder function after cell therapy. See the graphs below.

 

Figure 1: Graphs showing the progressive improvement in the different ASIA scores of the series, at different time points. PPS, Pin Prick Score; LTS, Light Touch Score; MS, Motor Score.

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Detailing significant improvements through several variables.

From the published research over the years regarding mesenchymal stem cells for spinal cord injury, it appears that multiple treatments over a period of six to 12 months is better.

 

As reported by Oh et al in 2015, “We found in our current investigation that a single MSC application therapy is very safe, but only produces a weak therapeutic effect. Therefore, an alternative method is needed to raise the effectiveness of MSC therapy. Multiple MSC injections may be more effective as seen in our previous study.”

 

In 2021, a Mumbai group conducted an open-label study including 180 sub-acute and chronic SCI patients. All patients received intrathecal autologous BMMNCs along with neurorehabilitation. 80–100 mL of bone marrow was aspirated and BMMNCs were obtained using density gradient separation. An average of 1.06 × 10⁸ cells (106 million) with 97% viability was administered through lumbar puncture. After transplantation, all patients underwent neurorehabilitation. Patients were followed up after an average of 9 ± 7 months. They were assessed for functional symptomatic changes and the outcome measures used were functional independence measure (FIM) and walking index for SCI (WISCI).

 

Patients showed symptomatic improvement in sitting/standing balance, bed mobility, trunk stability, upper limb function, mobility, sensation, bowel/bladder functions, and activities of daily living with no serious adverse events. Scores on FIM and WISCI showed statistically significant improvement.

 

On subgroup analysis, it was found that early intervention and more than one dose of BMMNCs demonstrate a better functional outcome.

 

Patients were divided into two groups: Intervention administered within 12 months from injury and after 12 months from injury. It was observed that FIM scores improved in 77.04% of patients who underwent cellular therapy within 12 months of injury and in 65% of patients who underwent cellular therapy after 12 months.

 

Fifty-four patients underwent a second dose. It was observed that a higher percentage of patients (79.62%) who were administered the second dose showed improvements as compared to those who underwent a single dose of cellular transplantation (65.07%).

Personalized treatment options are available. Call (844) GET-STEM today.

Why doesn’t R3 Stem Cell use a person’s own stem cells for SCI?

R3 used to perform autologous therapies, where a patient’s own bone marrow or adipose stem cells were 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.

How do the Stem Cells and Exosomes Work for Spinal Cord Injury?

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:

Angiogenesis

Provokes formation of new blood vessels.

Reduce inflammation

Lack of blood flow is associated with significant

Immune system modulation

The stem cells and exosomes modulate the immune system very differently than steroids. Instead of blanketly suppressing the immune system, the regenerative biologics tamp down the harmful processes while amping up the beneficial ones. This includes ramping up production of several helpful growth factors and cytokines, while tamping down harmful ones.

Cellular signaling

The biologics are able to perform “cell to cell” communication. This promotes recipient cells to proliferate their growth factor production, protein production, and regenerate nerve tissues that are damaged.

Prevent cell death

Most cells have a timed death, where they are only allowed to live a certain length of time. This is called apoptosis. The regenerative biologics allow normally functioning cells (i.e., neuron cells) to live longer and spare them from the pre-programmed death.

Preventing scar tissue

Spinal Cord Injury patients may experience significant scarring throughout the central nervous system. Once that scar tissue forms, it becomes nonfunctional. Stem Cells and exosomes are great at preventing scar tissue (anti-fibrosis).

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 treatment of Spinal Cord Injury, R3 Stem Cell often includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell-to-cell communication for new blood flow creation.

Schedule a consultation to discuss treatment options. Call us at (844) GET-STEM.

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 into 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 standards 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 which 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, 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 potentials. In fact, they have been shown to be anti-tumor forming.

 

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 potentials. In fact, they have been shown to be anti-tumor forming.

Talk to a team that specializes in regenerative medicine. (844) GET-STEM.

For the past decade, R3 has been successfully treating Spinal Cord 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.

 

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 with each procedure.

Similar to the research mentioned above, R3 Stem Cells outcomes for SCI have been exceptional! The patient satisfaction rate is 75% year over year for SCI. 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 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 SCI 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 Cells 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 Cells 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 (480) 808-7057 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.

Schedule your consultation and discuss your options. Call (844) GET-STEM.

References

About R3 Stem Cell

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 this Guide refer to procedures performed outside of the USA.

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