The Neurogenesis Project
Stem Cell Therapy
for Brain Injury & Neurological Conditions
Stem cell therapy for brain injury and neurological conditions at The Neurogenesis Project uses umbilical cord–derived mesenchymal stem cells (MSCs) as one component in a sequenced protocol designed to reduce neuroinflammation, support neural tissue repair, and modulate immune responses that damage the central nervous system.
Dr. Sean Orr uses mesenchymal stem cells not as a standalone injection but as one component in a sequenced program that prepares the tissue environment before the cells arrive and supports their activity afterward.
Available at our St. Marys, Georgia clinic.
How MSCs Work in Neurological Tissue
Paracrine signaling, immune modulation, and trophic support
The therapeutic value of mesenchymal stem cells in neurology comes less from their ability to differentiate into neurons (which remains limited in vivo) and more from their paracrine activity. Once administered, MSCs secrete a broad profile of anti-inflammatory cytokines, neurotrophic factors, and extracellular vesicles that act on surrounding tissue. This paracrine secretome includes vascular endothelial growth factor (VEGF), brain-derived neurotrophic factor (BDNF), insulin-like growth factor–1 (IGF-1), and hepatocyte growth factor (HGF).
A 2019 review by Uccelli et al. in The Lancet Neurology described MSCs as “pharmacies on demand” because the cells adjust their secretory profile in response to local tissue signals. In an inflamed neural environment, MSCs shift activated microglia from a pro-inflammatory M1 phenotype toward an anti-inflammatory M2 phenotype. They also suppress T-cell proliferation and promote regulatory T-cell expansion, which reduces autoimmune-driven neural damage.
Preclinical models of traumatic brain injury (TBI) published by Mahmood et al. in the Journal of Neurosurgery (2004) showed that intravenous MSC administration reduced lesion volume and improved functional recovery in rats, primarily through increased angiogenesis and reduced apoptosis at the injury site rather than through direct cell replacement. Subsequent human pilot studies have shown safety and preliminary efficacy signals, though large-scale randomized controlled trials are still in progress.
Clinical Applications in Neurology
Where MSC therapy fits within Dr. Orr’s practice
Neuroinflammation
Chronic microglial activation drives progressive neural damage in conditions ranging from post-concussion syndrome to early neurodegeneration. MSCs modulate this inflammatory cascade by shifting microglial polarization and suppressing pro-inflammatory cytokines including TNF-α, IL-1β, and IL-6, as demonstrated in multiple preclinical models published in Stem Cells Translational Medicine.
Traumatic Brain Injury Sequelae
Patients living with persistent cognitive, emotional, or somatic symptoms months or years after TBI may benefit from MSC therapy’s ability to reduce ongoing neuroinflammation and promote angiogenesis at injury sites. A Phase I/II trial by Cox et al. (2017) in Stem Cells established the safety of IV MSC administration in acute TBI patients and reported preservation of critical brain structures on follow-up MRI.
Early Cognitive Decline
When processing speed, working memory, or executive function begin to deteriorate before a formal dementia diagnosis, the window for intervention is at its widest. MSC-derived neurotrophic factors including BDNF and VEGF support neuronal survival and synaptic maintenance. Dr. Orr pairs MSC therapy with neurocognitive testing to track measurable changes in cognitive performance.
Autoimmune Neurological Damage
MSCs suppress autoreactive T-cell populations and promote regulatory T-cell expansion, which may benefit patients whose neurological symptoms stem from immune-mediated processes. Clinical trials in multiple sclerosis (Connick et al., The Lancet Neurology, 2012) demonstrated safety and structural preservation of the optic nerve after IV MSC infusion in progressive MS patients.
Post-Infectious Neurological Syndromes
Viral infections including SARS-CoV-2 can trigger persistent neuroinflammation, blood-brain barrier disruption, and microglial activation that outlasts the acute infection by months. MSC therapy targets the residual inflammatory state rather than the virus itself. Early clinical data from Lanzoni et al. (2021) in Stem Cells Translational Medicine showed reduced inflammatory markers following MSC infusion in COVID-19 patients with respiratory involvement.
Neuroprotection and Biological Aging
Age-related decline in endogenous stem cell populations contributes to reduced tissue repair capacity throughout the nervous system. Exogenously administered MSCs restore trophic factor availability and support vascular health in neural tissue. Patients in the Cellular Rejuvenation Program receive MSCs as part of a broader biological age reversal protocol that includes NAD+ repletion and exosome therapy.
How We Use MSCs Differently
A prepared environment, not a standalone injection
The majority of clinics offering stem cell therapy administer the cells in a single visit without pre-treatment preparation or post-treatment support. The cells arrive into whatever tissue environment happens to exist at the time. Dr. Orr’s approach is different: MSCs are delivered into a tissue environment that has been prepared in advance to receive them.
The logic is based on the biology. MSCs respond to local tissue signals. If the cellular environment is metabolically depleted, oxidatively stressed, and chronically inflamed, the cells spend their signaling capacity managing damage rather than promoting repair. By restoring NAD+ levels, reducing baseline inflammation, and optimizing mitochondrial function before MSC administration, the cells arrive into tissue that is ready to respond to their paracrine signals productively.
Prepare the Environment
Days 1–3 of the program
NAD+ IV infusions restore mitochondrial function. Anti-inflammatory support and targeted supplementation reduce baseline neuroinflammation. Neurocognitive testing and neuroimaging establish measurable baselines for tracking outcomes.
Administer MSCs
Into prepared tissue
Mesenchymal stem cells are infused intravenously once the tissue environment has been optimized. Exosome therapy may be administered in close sequence to amplify paracrine signaling. Dr. Orr monitors vital signs continuously throughout the infusion.
Support and Measure
Post-treatment and follow-up
Continued NAD+ support and targeted supplementation protect the cellular activity initiated by the MSCs. Follow-up neurocognitive testing and imaging at defined intervals quantify structural and functional changes. Outcomes are tracked by objective data, not self-report alone.
For patients interested in maintaining the regenerative benefits between visits, Dr. Orr developed Action Potential Supplements to provide physician-grade formulations that support mitochondrial function, manage neuroinflammation, and sustain the metabolic environment that stem cells depend on for ongoing activity.
Safety, Sourcing, and Regulatory Status
What patients should know before treatment
The MSCs used at The Neurogenesis Project are sourced from an FDA-registered HCT/P establishment operating in compliance with 21 CFR Part 1271. The cells are derived from donated human umbilical cord tissue (Wharton’s jelly), processed under current Good Manufacturing Practice (cGMP) conditions, and tested for sterility, endotoxin levels, mycoplasma, and cell viability before release. Each lot comes with a certificate of analysis documenting these results.
MSC therapy is not FDA-approved to treat, cure, or prevent any disease. Dr. Orr administers MSCs within his scope of medical practice under physician direction. Patients receive full informed consent documentation explaining the regulatory status, the distinction between FDA-registered tissue establishments and FDA-approved therapies, known risks, potential benefits, and alternative treatment options before any cells are administered.
The safety profile of IV MSC administration is well characterized in published literature. A 2012 meta-analysis by Lalu et al. in PLOS ONE, covering 36 clinical trials and 1,012 participants, found no association between MSC infusion and acute infusion toxicity, organ system complications, infection, or malignancy. The most commonly reported adverse event was transient fever, occurring in a small percentage of patients. At The Neurogenesis Project, all infusions are administered with continuous vital sign monitoring in a private clinical suite.
MSCs vs. Exosomes: Different Tools, Complementary Mechanisms
Exosomes are the extracellular vesicles that MSCs secrete. They carry the mRNA, microRNA, and proteins that direct much of the paracrine signaling attributed to stem cells. When administered alongside MSCs, exosomes amplify and extend the signaling activity. When administered alone, they deliver the paracrine payload without the live cells. Dr. Orr selects the appropriate combination based on the patient’s clinical profile, the target pathology, and whether the treatment goal is acute immune modulation, long-term trophic support, or both. Details on exosome therapy are available on the exosome therapy page.
Related Treatments and Programs
MSC therapy works best within a broader protocol
Program
Intensive Brain Health Program
A five- to ten-day concentrated protocol combining MSC therapy, NAD+ IV infusions, exosomes, neurostimulation, and advanced diagnostics under Dr. Orr’s direct supervision.
Learn about the Intensive Program →Program
Cellular Rejuvenation Program
A targeted regenerative protocol pairing mesenchymal stem cells with exosome therapy and metabolic support for patients focused on cellular repair and biological age reversal.
Explore the Cellular Rejuvenation Program →Treatment
Exosome Therapy
Exosomes carry the signaling molecules that direct MSC activity at the tissue level. When administered alongside stem cells, they amplify the paracrine effects that drive neural repair.
Read about exosome therapy →Treatment
NAD+ IV Therapy
Nicotinamide adenine dinucleotide delivered intravenously to restore mitochondrial function and create a metabolically favorable environment for stem cell engraftment and activity.
Explore NAD+ therapy →What to Expect
Pre-treatment evaluation and imaging
Estimated time: 45 minutes
Dr. Orr conducts a full neurological examination and reviews your brain imaging, laboratory results, and clinical history. This evaluation determines whether mesenchymal stem cell therapy is appropriate for your condition and identifies the specific neural targets for treatment.
Treatment planning and informed consent
Estimated time: 30 minutes
Dr. Orr explains the stem cell sourcing, expected biological mechanisms, potential risks, and realistic outcome expectations. He reviews the current evidence base for your specific condition and walks you through the procedural steps. You sign informed consent after all questions have been addressed.
Stem cell preparation and quality verification
Estimated time: 30 minutes
Mesenchymal stem cells from a qualified tissue bank are thawed and prepared according to strict handling protocols. Cell viability and count are confirmed before administration. The cells are drawn into syringes in a sterile environment.
Intravenous stem cell administration
Estimated time: 1 hour
The stem cells are delivered through a peripheral IV line over approximately 30 to 60 minutes. Vital signs are monitored throughout the infusion. Some patients receive adjunctive IV therapies such as NAD+ or glutathione in the same session to support the cellular environment.
Post-procedure monitoring and recovery plan
Estimated time: 30 minutes
You are monitored for at least 30 minutes after the infusion for any immediate reactions. Dr. Orr provides post-treatment instructions, schedules follow-up imaging and laboratory tests at defined intervals, and outlines what changes to look for in the weeks following treatment.
Frequently Asked Questions
Common questions about MSC therapy at The Neurogenesis Project
What are mesenchymal stem cells, and where do they come from?
They are cells that can reduce inflammation and help repair tissue. Ours come from donated umbilical cord tissue, processed by FDA-registered tissue banks and tested for safety before use.
Read the full answer
Mesenchymal stem cells (MSCs) are multipotent stromal cells capable of differentiating into several cell types and, more importantly for neurology, secreting anti-inflammatory cytokines and growth factors that modulate the immune system and support tissue repair. The MSCs used at The Neurogenesis Project are sourced from an FDA-registered HCT/P establishment that operates in compliance with 21 CFR Part 1271. They are derived from donated human umbilical cord tissue (Wharton’s jelly), processed under cGMP conditions, and tested for sterility, endotoxin, and viability before release.
Is MSC therapy FDA-approved?
No. Stem cell therapy is not FDA-approved for any disease. It is administered by Dr. Orr under his medical license, and every patient receives full informed consent before treatment.
Read the full answer
No. MSC therapy is not FDA-approved to treat, cure, or prevent any disease. The cells are classified as human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271 and are administered under physician direction as part of a clinical protocol. Dr. Orr provides MSC therapy within his scope of medical practice, and patients receive full informed consent documentation explaining the regulatory status, known risks, and expected outcomes before treatment begins.
How is MSC therapy at The Neurogenesis Project different from what other clinics offer?
Most clinics give stem cells as a standalone treatment. We combine them with other therapies in a sequenced protocol and track outcomes with brain imaging and cognitive testing, not just how you feel.
Read the full answer
Most clinics administer stem cells as a standalone injection and send patients home. Dr. Orr treats MSCs as one component within a sequenced neurological protocol. The cells are administered alongside NAD+ IV therapy, exosome infusions, and targeted supplementation designed to prepare the tissue environment before the cells arrive and support their activity afterward. Pre-treatment neuroimaging and neurocognitive testing establish a measurable baseline so outcomes are tracked objectively, not by subjective report alone.
What conditions might benefit from MSC therapy?
Patients with brain injuries, post-concussion problems, early cognitive decline, and chronic brain inflammation are the most common candidates. Dr. Orr determines eligibility during the initial evaluation.
Read the full answer
The strongest preclinical and early clinical evidence supports MSC therapy for neuroinflammatory conditions, neurodegenerative processes, and immune-mediated neurological damage. Patients with traumatic brain injury sequelae, post-concussion syndrome, early cognitive decline, chronic neuroinflammation, and autoimmune-related neurological symptoms are the most common candidates Dr. Orr evaluates. Candidacy is determined during the initial neurological workup, not by diagnosis label alone.
What does a treatment session involve?
The stem cells are given through an IV over about 45 to 60 minutes. Most patients feel nothing beyond the IV needle. You are monitored for 30 to 60 minutes afterward.
Read the full answer
MSC therapy is administered intravenously over approximately 45 to 60 minutes in a private clinical suite with continuous vital sign monitoring. Most patients report no discomfort beyond the IV placement itself. The session is typically scheduled within the Intensive Brain Health Program alongside other interventions so the MSCs are delivered into a tissue environment that has been prepared by prior NAD+ infusions and anti-inflammatory support. Patients remain under observation for 30 to 60 minutes afterward.
How much does MSC therapy cost?
$5,500 per session. Most patients receive it as part of a bundled program at a program rate. Insurance does not cover it.
Read the full answer
MSC therapy at The Neurogenesis Project is $5,500 per session. This covers the cells themselves, physician administration, monitoring, and follow-up assessment. Most patients receive MSCs as part of the Intensive Brain Health Program or the Cellular Rejuvenation Program, which bundle multiple interventions at a program rate. Insurance does not cover MSC therapy at this time. Our patient coordinator provides a full cost breakdown before treatment.
Where does The Neurogenesis Project source its stem cells?
From donated umbilical cord tissue, processed by FDA-registered tissue banks. Each batch is tested for safety and quality before use.
Read the full answer
We source mesenchymal stem cells from donated umbilical cord tissue collected from healthy donors following cesarean deliveries. The tissue is processed by FDA-registered tissue banking facilities. Each lot is tested for sterility, viability, and cell surface marker expression. We do not use adipose-derived or bone marrow-derived stem cells from the patient's own body, as the evidence for cord-derived MSCs in neurological applications is stronger and cell quality is more consistent.
Has the FDA issued any warnings about stem cell products?
Yes. The FDA has acted against clinics that operate outside the rules. Our stem cells come from FDA-registered tissue banks, and we are transparent about the regulatory status with every patient.
Read the full answer
Yes. The FDA has taken enforcement action against clinics operating outside the regulatory framework. Our products come from FDA-registered tissue banks, and we administer them in compliance with HCT/P regulatory guidance. We do not market stem cell therapy as FDA-approved for any specific disease and discuss the regulatory status directly with every patient.
Is stem cell therapy covered by insurance?
No. Stem cell therapy is entirely out of pocket. We provide documentation, but reimbursement is unlikely given the current regulatory status.
Read the full answer
No. MSC therapy is not covered by any commercial insurance plan or Medicare. It is an out-of-pocket expense. We provide superbills but reimbursement is unlikely given the current regulatory status. We are transparent about costs and recommend stem cell therapy only when the clinical evaluation identifies a patient likely to benefit.
Find Out Whether MSC Therapy
Fits Your Neurology
Dr. Orr evaluates every patient individually. A consultation determines whether mesenchymal stem cells are appropriate for your condition and, if so, how they should be sequenced alongside other interventions for the best outcome.
Book a $250 ConsultationOr call (912) 268-3097 to speak with our patient coordinator.