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Postnatal Derived Stem Cells & Tissue Product. HCT/P

Stem Cells:
ALS Treatment Breakthrough

"Stem cell (SC) therapy is considered one of the most promising therapeutic approaches for ALS. With this therapy, various pathogenic mechanisms could be targeted to slow the progression of the disease. SC therapy could provide both trophic and immunomodulatory support and potentially allow for the regeneration of motor neurons (22)." 

This page is intended to provide information about our stem cell therapy and is not a substitute for professional advice, diagnosis, or treatment. The therapy we offer is designed to support individuals in managing neurodegenerative diseases, but it is not a cure for any specific condition. If you have any concerns, we strongly recommend consulting with a qualified professional for personalized guidance and treatment. Remember that individual experiences may vary, and results are not guaranteed.

Cell therapy for incurable neurodegenerative diseases 

Thanks to stem cell therapy, we can not only slow down the progression of incurable brain diseases like Parkinson's, Alzheimer's, and Huntington's but also address the root of the problem. In the field of neuroscience, the discovery of neural stem cells has disproven the earlier belief that adult brains couldn't create new brain cells. (6,7) These neural stem cells can enhance cognitive function in experimental studies with rodents mimicking Alzheimer's disease. (8,9,10) A study by Awe (11) and colleagues used human skin cells to create neural stem cells for potential Alzheimer's treatment. In the case of Parkinson's disease, where brain cell loss is localized, we can efficiently generate replacement neurons from certain types of stem cells. This makes Parkinson's disease an excellent candidate for stem cell therapy. (12)


The Use of Stem Cells in ALS

In their 2023 paper by Najafi et al., the authors provide a comprehensive review of Mesenchymal Stem Cell (MSC) therapy for Amyotrophic Lateral Sclerosis (ALS) patients. (13) They summarize how MSCs can significantly improve ALS and propose the mechanisms behind their action. According to their research, MSCs play a crucial role in addressing neurological diseases like ALS because they can transform into neuronal cells, replacing damaged and deceased cells with new, functional ones. Furthermore, MSCs enhance the neuron environment by releasing growth factors and removing harmful substances, thereby safeguarding neurons. (14)

These stem cells also contribute to repairing damaged nerve structures such as dendrites and axons, and they stimulate alternative brain pathways, leading to better movement and coordination in ALS patients. (15) All of these remarkable qualities make MSCs a promising source for cell therapy and regenerative medicine. To illustrate these effects, the authors have included a schematic figure that depicts some of the ways in which mesenchymal stem cells aid in restoring neurons in ALS patients.
 

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Proposed mechanisms of neurorestoration by mesenchymal stem cells

 

Mesenchymal stem cells (MSCs) release a range of important substances, including cytokines and growth factors, such as neurotrophic factors like transforming growth factor (TGF)-1 and vascular endothelial growth factor (VEGF). These substances play a critical role in protecting neurons, stimulating the natural growth of neurons, promoting the formation of new neurons, enhancing blood vessel growth, facilitating the reconnection of nerve synapses, and remyelinating damaged nerve fibers. Additionally, they help reduce cell death (apoptosis) and regulate inflammation primarily through their paracrine actions. (Figure created using Adobe Illustrator 2020) (13)

In two separate studies with a 6-month follow-up period, Oh et al. found that ALS patients who received 2 injections of BM-MSCs experienced a slower decline in their ALSFRS-R scores, indicating a clinical benefit during the study period (16). Furthermore, Gugliandolo and colleagues reported that the loss of motor neurons might also be diminished, leading to a delay in the loss of motor function. These findings have spurred interest in the use of mesenchymal stem cells (MSC) as a potential treatment for ALS patients (21).

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The function of these cells is to enable the healing, growth, and replacement of cells that are lost or damaged. They can differentiate into many options including: 

  • Mesenchymal stem cells: present in many tissues, in bone marrow, these cells differentiate mainly into the bone, cartilage, and fat cells. As stem cells, they are an exception because they act pluripotently and can specialize in the cells of any germ layer.

  • Neural cells give rise to nerve cells and their supporting cells—oligodendrocytes and astrocytes.

  • Haematopoietic stem cells form all kinds of blood cells: red, white, and platelets. (1) 

"In recent years, stem cell therapy has become a very promising and advanced scientific research topic. Stem cells are unspecialized cells of the human body. They are able to differentiate into any cell of an organism and have the ability of self-renewal." (1)

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Rejuvenation by Cell Programming 

Ageing is a reversible epigenetic process. The first cell rejuvenation study was published in 2011 (2). Cells from aged individuals have different transcriptional signatures, high levels of oxidative stress, dysfunctional mitochondria, and shorter telomeres than in young cells (3). There is a hypothesis that when human or mouse adult somatic cells are reprogrammed to stem cells, their epigenetic age is virtually reset to zero (4). This was based on an epigenetic model, which explains that at the time of fertilization, all marks of parenteral ageing are erased from the zygote’s genome and its ageing clock is reset to zero (5).

Stem Cells in Neurodegenerative Disease

Stem cells have the ability to turn into neurons, i.e. nerve cells when they touch dying nerve cells which is why there are used in the treatment of neurodegenerative disease. They also have the ability to turn into the muscle cells which is why they are thought to support weakened muscles. 
After several decades of experiments, stem cell therapy is becoming a magnificent game changer for medicine. Currently, untreatable neurodegenerative diseases have the possibility of becoming treatable with stem cell therapy. With stem cell therapy and all its regenerative benefits, we are better able to prolong human life than at any time in history. (1)
 

Details of Postnatal Derived Stem Cells

How Are These Postnatal Cells Harvested? Cleanest Harvesting Practices

This product comes from the world's cleanest donors. Our partner lab ensures a 100% Chain of Custody for tissue collection. Donors (both parents) and three generations of family members, undergo rigorous screening, including medical history interviews, physical examinations, behavioral risk assessments, and more. Only healthy families meeting these criteria are considered. The strictest ethical sourcing standards are maintained. The product is screened for genetic and environmental factors including heritable and non-heritable conditions, diseases, and contaminants from substances like medications, tattoos, alcohol, drugs, tobacco, and vaping. Donors are also verified to be Covid MRNA Vaccine-free. An independent lab, compliant with CLIA, FDA-registered, CMS-certified, and CAP and AABB accredited, thoroughly analyzes and certifies the product.

Postnatal Cells (HCT/P). More Than Just Stem Cells

This is a Human Cellular Tissue allograft, often abbreviated as HCT/P. Unlike other regenerative biologics in the market, which are mesenchymal stem cells (MSC) or exosomes, HCT/P is a complete blend of MSCs, exosomes, and progenitor cells. What makes this unique is it’s natural handling. Cells have not been damaged by aggressive extraction, put into synthetic growth mediums or artificially expanded. Instead, it is minimally processed and nurtured in post-natal material, like  the natural process that occurs in the womb. Unlike stem-cell-only products, HCT/P contains all the essential components necessary for human life, healing, and regeneration.

Infection Screening

Extensive testing is completed for: Hepatitis Bs Ag, Hepatitis BC Ab, HTLV I/II Ab, Hepatitis BC Ab, Hepatitis C Ab, HIV 182 Plus O Ab, CMV Ab, RPR (Non-treponemal syphilis), HIV-1/HCV/HBV NAT (Ultrio), WNV NAT, and 14-day Quarantine testing for Bacteria & Fungus. 

Why We Administer by Intrathecal Spinal Injection

Although administration can be intravenous (IV) or intramuscular injections (IM), intrathecal spinal injection continues to be the gold standard for neurodegenerative disorders.​

  • Many trials including NurOwn have supported intrathecal injections of stem cells and as safe and efficacious 

  • Better distribution and delivery of cells into the brain and spinal cord

  • Minimally invasive procedure with a good side effect profile

  • Performed by an Anesthesiologist with over 20 years of experience:  Since this procedure is done by making a tiny injection and placing the cells into the intrathecal space it is always done by an medical doctor who is an Anesthesiologist.  

Why We Don’t Use Your Own Cells

Some studies found that MSCs derived from ALS patients showed reduced properties compared to healthy MSCs.  Koh and coworkers suggested that pluripotency and the secretion of trophic factors of the BMMSCs derived from ALS patients were reduced in proportion to a poorer prognosis, suggesting that allogeneic BMMSCs from healthy donors may be a better option for MSC therapy in ALS patients [69].

Made in the USA

This product is manufactured in the USA adhering to the most stringent safety and purity regulations

This product is FDA compliant but not FDA approved. We do not claim that they cure, treat or prevent any conditions or disease.

Extracellular allografts (HCT/P) is a non-manipulated human tissue product. It is FDA compliant ensuring that regulations for purity and safety have been met. By comparison, traditional stem cells are manipulated and non-FDA compliant. Extracellular allografts (HCT/P) comply with U.S. Food and Drug Administration's (FDA) regulations in Title 21 Part 1271 of the Code of Federal Regulations, Section 361 of the Public Health Service Act and Good Laboratory Practices (GLP)

About the Cells We Use

This is a pluripotent Human Cellular Tissue allograft products, (HCT/P)
Here is why we chose Extracellular Matrix allografts compared to other regenerative biologics on the market:

Extracellular allografts are an HCT/P. The HCT/P allografts we use are FDA compliant and manufactured in accordance with its quality management system, which complies with the U.S. Food and Drug Administration's (FDA) regulations contained in Title 21 Part 1271 of the Code of Federal Regulations, Section 361 of the Public Health Service Act and Good Laboratory Practices (GLP). These HCT/P allografts are not FDA approved. We do not claim that they cure, treat, or prevent any conditions or diseases. 

The Extracellular product we use is manufactured in the USA and harvested from the cleanest donors in the world! The manufacturer has a 15-year history of FDA compliance and excellent laboratory practices. 

In the beautiful State of Utah, there is a unique environment of mothers that live a very clean and healthy lifestyle. The Laboratory that we use prides itself in their 100% Chain of Custody of the tissue gathering process. 

Ethical Sourcing and Safety

The proprietary process begins with meticulous screening of the donor mother and father, as well as three generations of family members. In addition to routine industry screens for blood borne pathogens, they also screen for heritable and non-heritable conditions, environmental contaminants from medications, tattoos, alcohol, drugs, tobacco, and electronic vaping.  Blood testing is performed by an independent lab who complies with CLIA standards and is registered with the FDA, certified by CMS and accredited by CAP and AABB. 

Medical records for each donor are screened for information pertaining to risk factors for relevant communicable diseases. The screening includes a medical history interview, physical examination, behavioral risk assessment and information from other sources or records which may pertain to donor suitability. Only healthy families who meet or exceed these criteria are considered. 

Postnatal tissue donations are promptly collected from local hospitals minutes away by their recovery specialists following a healthy cesarean birth. After processing, allografts are tested again to ensure they are free of contaminants or infection, and contain healthy, viable cells prior to cryopreservation. 

Viral testing and Bacteriology   

The lots are quarantined for 14 days and thoroughly tested for bacterial, communicable, and other disease contamination by a CLIA-certified lab. Additional testing is conducted in multiple phases of the process to ensure zero contamination.

Testing is very important to prevent Graft-Versus-Host Disease to ensure this is the safest HCT/P available.
 

Cryopreservation & avoiding any chemical or toxins: 

We use a unique cryopreservation technique that includes using the source's own natural components preserved with a natural cryoprotectant to help ensure maximum functionality at time of use. This creates industry leading bioavailability of the cells. 

WHERE OUR CELLS COME FROM

Most other Regenerative Biologics products just contain 'one’ specific type of the following:

•    Umbilical Cord blood Cell
•    Umbilical Tissue Cell 
•    Placenta Cell
•    Exosome 

At BodyScience, we use a cellular matrix that does not just have one specific tissue but rather all of the tissues that create life in the womb.

What also makes this HCT/P allograft unique is that the product is minimally manipulated and contains the natural postnatal source material which includes:

•    Mesenchymal Stem Cells 
•    Progenitor Cells 
•    Exosomes
 

Price

For stem cells, under the “price” lets remove the prices and amount and replace with the statement:  Stem cell therapy pricing can vary depending on volume of stem cells used and method of administration (IV, IM or Intrathecal).  Number of cells, frequency and route of administration are typically made based on your symptoms or diagnosis, degree of progression and length of time with the condition.  For more information please contact our office. 

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Alternatives

Mesenchymal Stem Cells

Progenitor Cells

Exosomes

MSC's share two qualifying characteristics. Firstly, all stem cells have the potential to differentiate into multiple types of cells. Secondly, stem cells are capable of unlimited self-replication via asymmetric cell division, a process known as self-renewal. Every cell in the human body originates from stem cell precursors.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7223321/#:~:text=MSCs%20can%20promote%20neovascularization%2C%20increase,vesicles%20%5B5%2C%206%5D.

All tissue cells, including stem cells, produce exosomes, packaged payloads of growth factors, cytokines, and other factors destined for secretion from the cell.  https://cellandbioscience.biomedcentral.com/articles/10.1186/s13578-019-0282-2
 

How is the procedure performed and why we use intrathecal administration into the lumbar spinal cord region 

Many trials have supported intrathecal injections of SCs as safe and efficacious (17, 30–32). It allows for better distribution and potentially increases the delivery of cells into the subarachnoid space and access to the brain parenchyma. The intrathecal approach also allows repeated injections of SCs to be considered a minimally invasive procedure with a good side effect profile. Microglial cells have been implicated in the progression of ALS by accelerating neuronal death. Intrathecal MSCs have been proposed to induce an anti-inflammatory state, particularly by switching the phenotype of microglial cells from the proinflammatory M1 to the anti-inflammatory M2 (33). 

Many trials have supported intrathecal injections of SCs as safe and efficacious (16, 17, 18). It allows for better distribution and potentially increases the delivery of cells into the subarachnoid space and access to the brain parenchyma. The intrathecal approach also allows repeated injections of SCs to be considered a minimally invasive procedure with a good side effect profile. Microglial cells have been implicated in the progression of ALS by accelerating neuronal death. Intrathecal MSCs have been proposed to induce an anti-inflammatory state, particularly by switching the phenotype of microglial cells from the proinflammatory M1 to the anti-inflammatory M2 (19).
 

Who Will Perform this Procedure? Safety and Side Effects

  • This procedure is done by making a tiny injection and placing the cells in the intrathecal space around the spinal cord.  It is always performed by a medical doctor who is an Anesthesiologist.  

  • At BodyScience we have been administering cells through intrathecal administration since 2019 

  • What are common Side Effects: and Have there been any serious Side Effects:  The most common side effect is a headache the following day that can last a few hours. That happens in approximately 20% of patients. To date, we have never had any serious side effects. 

How Many and How Often are Cells Administered

•    Common dosing strategies for administration is single administration, twice per year, or three sessions forty-five days apart.
•    The treatment protocol is precisely adjusted according to the patient's condition and symptoms and a different protocol is applied for each patient.   The amount of cells administered may vary depending on age and weight. 

Other Stem Cell Therapies in ALS

NurOwn: This experimental medication is being developed as a potential treatment for ALS and is currently in phase 3 clinical trials. It is a cell-based therapy that uses mesenchymal stem cells (MSCs) to help modulate the immune system and reduce inflammation in the body.

In the NurOwn, randomized clinical trial in patients with ALS: Safety, clinical, and biomarker results, participants received three treatments of MSC-NTF or placebo intrathecally.33% of MSC-NTF and 28% of placebo participants met clinical response criteria at 28 weeks. A pre-specified analysis of participants' response rate at 28 weeks was 35% MSC-NTF and 16% placebo. Significant improvements in cerebrospinal biomarkers of neuroinflammation, neurodegeneration, and neurotrophic factor support were observed with MSC-NTF, with the placebo unchanged. The treatment was well tolerated by patients but did not reach statistical significance. (23)

Update and availability for NurOwn: as of September 2023, FDA advisory committee voted against NurOwn approval for ALS. 

Details About Scheduling Your Visit. 

We are an outpatient facility, this means that you will only be in the clinic for the duration of the treatments each day. You are responsible for booking your own travel & accommodations. 

Day 1: Arrival to Miami
Day 2: IV therapies to ensure you are hydrated and fully prepared for therapy (half day)
Day 3: Stem cell infusion (1-2 hours)
Day 4: Follow-up physical and post treatment IV hydration therapy (1-2 hours)
Day 5: Departure

The procedure is minimally invasive and has very little downtime.
We recommend getting plenty of sleep during these days and avoiding things that cause inflammation. An anti-inflammatory diet removing gluten, shellfish, dairy, peanuts and alcohol is recommended. Reducing stress is important. 
Our facility is handicap accessible. We routinely treat people with ALS.  We understand your specific needs and are set up to handle them. 
 

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Can stem cell therapy cure ALS?

There is currently no cure for ALS, and treatment options are limited to medications that can slow the progression of the disease and supportive care to manage symptoms.
Several clinical trials have investigated stem cell therapy as a potential treatment for ALS. Some of these studies have shown promising results, while others have not.

Compliance

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The HCT/P allografts we use are FDA compliant and manufactured in accordance with its quality management system and complies with the U.S. Food and Drug Administration's (FDA) regulations contained in Title 21 Part 1271 of the Code of Federal Regulations, Section 361 of the Public Health Service Act and Good Laboratory Practices (GLP). These HCT/P allografts are not FDA approved. We do not claim that they cure, treat, or prevent any conditions or diseases. 

Scientific Studies

(1) Zakrzewski W, Dobrzyński M, Szymonowicz M, Rybak Z. Stem cells: past, present, and future. Stem Cell Res Ther. 2019 Feb 26;10(1):68. doi: 10.1186/s13287-019-1165-5. PMID: 30808416; PMCID: PMC6390367. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6390367/

 

(2) Lapasset L, Milhavet O, Prieur A, Besnard E, Babled A, Aït-Hamou N, Leschik J, Pellestor F, Ramirez JM, De Vos J, Lehmann S, Lemaitre JM. Rejuvenating senescent and centenarian human cells by reprogramming through the pluripotent state. Genes Dev. 2011;25:2248–2253. [PMC free article] [PubMed] [Google Scholar]

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(4) Petkovich DA, Podolskiy DI, Lobanov AV, Lee SG, Miller RA, Gladyshev VN. Using DNA methylation profiling to evaluate biological age and longevity interventions. Cell Metab. 2017;25:954–960. [PMC free article] [PubMed] [Google Scholar]

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(6) Ma DK, Bonaguidi MA, Ming GL, Song H. Adult neural stem cells in the mammalian central nervous system. Cell Res. 2009;19:672–682. doi: 10.1038/cr.2009.56. [PMC free article] [PubMed] [CrossRef] [Google Scholar]

 

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(14)Tavakol-Afshari J, Boroumand AR, Farkhad NK, Moghadam AA, Sahab-Negah S, Gorji A. Safety and efficacy of bone marrow derived-mesenchymal stem cells transplantation in patients with amyotrophic lateral sclerosis. Regen Ther. 2021;18:268–74. [PMC free article] [PubMed] [Google Scholar] [Ref list]

 

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(21) Gugliandolo, A., Bramanti, P., & Mazzon, E. (2019, March

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(22)  Aljabri A, Halawani A, Bin Lajdam G, Labban S, Alshehri S, Felemban R. The Safety and Efficacy of Stem Cell Therapy as an Emerging Therapy for ALS: A Systematic Review of Controlled Clinical Trials. Front Neurol. 2021 Dec 1;12:783122. doi: 10.3389/fneur.2021.783122. PMID: 34938264; PMCID: PMC8685950.

 

(23) Berry JD, Cudkowicz ME, Windebank AJ, Staff NP, et al. NurOwn, phase 2, randomized, clinical trial in patients with ALS: Safety, clinical, and biomarker results. Neurology. 2019;93(24):e2294–e2305. doi: 10.1212/WNL.0000000000008620. [PMC free article] [PubMed] [CrossRef] [Google Scholar] [Ref list]

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