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Umbilical cord–derived mesenchymal stem cells (UC-MSCs) represent an emerging area of regenerative medicine being studied for their potential role in musculoskeletal repair, immunomodulation, and tissue signaling. At Intercoastal Health, we approach regenerative medicine stem cell–based therapies with a strong emphasis on evidence review, regulatory awareness, appropriate patient selection, and transparency.
UC-MSC therapy is investigational for orthopedic and musculoskeletal conditions and is not FDA-approved for these indications. Our role is to help patients understand the current science, limitations, and realistic expectations within an ethical, clinician-guided framework.
Umbilical cord stem cells are mesenchymal stem cells isolated from donated umbilical cord tissue, most commonly Wharton’s jelly.
These cells demonstrate high proliferative capacity and paracrine signaling activity, meaning their effects are primarily mediated through
immune modulation and growth factor release, rather than direct tissue replacement.
UC-MSCs are distinct from embryonic stem cells and are obtained from ethically donated postnatal tissue.
Umbilical cord–derived mesenchymal stem cells (UC-MSCs) are being studied for their potential role in musculoskeletal repair through immunomodulation and biologic signaling rather than direct tissue replacement.
Rather than becoming new tissue, UC-MSCs primarily act through paracrine signaling—releasing growth factors and cytokines that influence inflammation and healing pathways.
Umbilical cord stem cells demonstrate higher proliferative capacity and lower immunogenicity compared to adult-derived stem cells, allowing for allogeneic use in research settings.
UC-MSC therapy for orthopedic conditions remains investigational and is not FDA-approved. At Intercoastal Health, discussions emphasize education, safety, and evidence limitations.
Patients with mild to moderate knee osteoarthritis (Kellgren–Lawrence grade II–III) represent the population with the strongest emerging evidence.
Candidates typically have persistent symptoms despite physical therapy, activity modification, oral medications, or standard injections.
Patients must understand that stem cell therapy is not curative and outcomes vary widely based on diagnosis, disease severity, and biologic response.
Advanced joint degeneration or conditions lacking supportive evidence may be better managed with alternative therapies.
Proposed Biologic Mechanisms: UC-MSCs appear to influence healing primarily through signaling and immune modulation.
Reduction of inflammatory cytokines such as IL-1β and TNF-α may help regulate chronic joint inflammation.
Stem cells may support cartilage cell survival by influencing apoptotic pathways.
Release of IL-10 and TGF-β supports extracellular matrix synthesis and tissue homeostasis.
Rather than rebuilding tissue directly, UC-MSCs may create conditions more favorable for repair.
These mechanisms remain under investigation and continue to evolve as research advances.
The most studied indication, with meta-analyses demonstrating improvements in pain and function at 6–12 months in select patient populations.
Preclinical evidence to ligament injuries suggests benefit.
Early studies suggest improvements in cartilage quality and extracellular matrix production, though long-term durability remains uncertain.
Preclinical data are promising, but high-quality human clinical trials are limited.
Emerging evidence suggests potential benefit to intervertebral disc degeneration, but stem cell therapy for disc disease remains experimental.
Evidence strength varies significantly, reinforcing the need for diagnosis-specific decision-making.
Clinical studies show statistically significant improvements in pain and function for select knee osteoarthritis populations.
Lower cell doses have demonstrated more favorable outcomes than higher doses in some trials.
Most studies involve small sample sizes, short follow-up periods, and heterogeneous protocols.
Large, multicenter randomized trials are lacking, and no standardized dosing or preparation protocols exist.
Current evidence supports cautious optimism—not routine use.
An Ethical, Informed Approach
Umbilical cord–derived stem cell therapies have been generally well tolerated in controlled studies. The most commonly reported risks include post-injection soreness, localized swelling, and temporary inflammatory reactions. Higher cell doses have been associated with increased swelling in some trials. As with any injection-based procedure, there is a low risk of infection or localized tissue irritation.
Stem cell therapy may be deferred or not recommended in certain situations, including active infection, uncontrolled medical conditions, advanced joint degeneration where evidence is limited, or when regulatory and evidence considerations do not support its use. Because these therapies remain investigational and are not FDA-approved for musculoskeletal conditions, careful patient selection and informed consent are essential.
At Intercoastal Health, stem cell therapy is approached with clinical rigor, ethical responsibility, and patient education at the forefront.
We prioritize informed decision-making, appropriate patient selection, and transparency—rather than one-size-fits-all regenerative solutions.
Our care is guided by licensed medical professionals with focused experience in musculoskeletal medicine and regenerative decision-making—not protocol-driven injection models.
We base recommendations on current peer-reviewed research, clinical guidelines, and known limitations of stem cell therapies, clearly explaining where evidence is supportive and where uncertainty remains.
Stem cell therapies for orthopedic conditions remain investigational. We adhere to FDA guidance, avoid unsupported claims, and ensure patients understand regulatory status before proceeding.
Every patient receives a personalized evaluation that considers diagnosis, disease severity, prior treatments, and realistic goals. When stem cell therapy is not appropriate, we discuss alternative options openly.
At Intercoastal Health, regenerative care begins with education, integrity, and individualized clinical judgment.
Umbilical cord stem cells are special cells collected from the umbilical cord and cord blood after a baby is born. There are two main types:
Hematopoietic stem cells (HSCs) — Found in cord blood, these cells can develop into all types of blood cells. They are FDA-approved for treating blood cancers (leukemia, lymphoma) and genetic blood disorders.
Mesenchymal stem/stromal cells (MSCs) — Found in cord blood and cord tissue (Wharton’s jelly), these cells can develop into bone, cartilage, and fat cells. They also have anti-inflammatory and immune-regulating properties. These are currently investigational and NOT FDA-approved for conditions like arthritis or aging.
Only cord blood hematopoietic stem cells are FDA-approved, and only for specific conditions:
Blood cancers (leukemias, lymphomas)
Genetic disorders of the blood and immune system
Sickle cell disease
Certain metabolic disorders
The FDA has NOT approved umbilical cord stem cell products for:
Osteoarthritis or joint pain
Anti-aging treatments
Sports injuries
Chronic pain
COVID-19 prevention or treatment
Umbilical cord mesenchymal stem cells (UC-MSCs) work through several mechanisms:
Differentiation — They can transform into specialized cells like cartilage, bone, or fat cells
Paracrine effects — They release growth factors and healing molecules that help repair damaged tissue
Immunomodulation — They help regulate the immune system and reduce inflammation
Anti-inflammatory effects — They decrease harmful inflammatory chemicals in the body
Anti-fibrotic effects — They may help reduce scarring in tissues
Research is ongoing for many conditions, though most remain investigational:
Conditions with the most clinical trial evidence:
Cerebral palsy in children
Knee osteoarthritis (mild to moderate)
Type 1 diabetes
Stroke recovery
Conditions under early investigation:
Intervertebral disc degeneration
Rotator cuff injuries
Liver disease
Heart disease
Autoimmune conditions (lupus, rheumatoid arthritis)
Neurological conditions (autism, developmental delays)
Important: None of these regenerative medicine applications are currently FDA-approved.
Clinical trials show promising but preliminary results for knee osteoarthritis:
Meta-analyses suggest UC-MSCs may improve pain and function scores at 6-12 months
Lower doses (25 million cells) may work better than higher doses
One randomized trial showed UC-MSCs were superior to steroid injections at 12 months
A 2025 Cochrane review concluded stem cells “may slightly improve pain and function” but evidence certainty is low
Bottom line: Results are encouraging but more large, high-quality studies are needed before this can be considered a proven treatment.
Based on available clinical trial data:
Onset of effects:
Some patients report improvement within 1-3 months
Maximum benefits typically seen at 6-12 months after treatment
Duration of effects:
Most studies only follow patients for 6-24 months
One study in children with developmental delays showed dramatic improvement up to 12 months, with slower progress thereafter
Long-term durability beyond 2 years is not well established
Important: Results vary significantly between individuals, and some patients may not respond to treatment.
Overall safety appears favorable based on clinical trial data:
A meta-analysis of 62 randomized trials (3,546 patients) found no serious adverse events such as death, infection, or cancer
A systematic review of 93 studies (2,001 patients) reported no long-term adverse effects, tumor formation, or cell rejection
Common mild side effects include:
Temporary fever (most common)
Injection site reactions
Temporary joint swelling (especially with higher doses)
Fatigue
Mild pain at injection site
However, serious safety concerns exist with unregulated clinics:
The CDC investigated bacterial infections in patients who received contaminated umbilical cord products from unregulated sources
Products from unregulated clinics may not meet safety standards
You should NOT receive umbilical cord stem cell therapy if you have:
Active infection or sepsis
Active cancer (especially blood cancers)
Known allergy to components of the cell product
Treatment may need to be delayed or avoided if you have:
Weakened immune system
Pregnancy (insufficient safety data)
Blood clotting disorders (for certain injection routes)
Costs vary significantly depending on the source and application.
Regenerative medicine treatments (at clinics):
Costs typically range from $5,000 to $25,000+ per treatment
These are generally NOT covered by insurance since they are investigational
Multiple treatments may be recommended
Public cord blood banking is recommended by ACOG and AAP:
Free of charge
Cord blood is available to anyone who needs a transplant
Supports patients of all backgrounds, especially those from underrepresented ethnic groups
Private cord blood banking may be considered if:
A family member has a medical condition (cancer or genetic disorder) that could benefit from cord blood transplant
You understand the very low probability of use (estimated 1 in 400 to 1 in 2,500 lifetime chance of needing autologous transplant)
Private banking is NOT recommended for:
“Biological insurance” against future unknown diseases
Potential regenerative medicine uses (not proven)
Before considering umbilical cord stem cell therapy, ask:
Is this treatment FDA-approved for my condition?
Is this part of a registered clinical trial?
What is the source of the cells and how are they processed?
What are the realistic expectations for improvement?
What are the potential risks and side effects?
How many treatments will I need and what is the total cost?
Will my insurance cover any portion of the treatment?
What other treatment options are available for my condition?
The strongest and most consistent evidence supports mild to moderate knee osteoarthritis. Multiple meta-analyses and randomized controlled trials show improvements in pain and function, particularly within the first 6–12 months after treatment. Emerging but more limited evidence also exists for cartilage regeneration, rotator cuff repair (as a surgical adjunct), and intervertebral disc degeneration.
Umbilical cord mesenchymal stem cells (UC-MSCs) primarily act through immunomodulation and paracrine signaling rather than directly replacing damaged tissue. Research shows they may reduce inflammatory cytokines in the joint, promote cartilage matrix production, and support tissue repair by releasing growth factors and anti-inflammatory mediators.
Not necessarily. Recent studies demonstrate an inverse dose-response relationship, meaning lower cell doses often perform better than higher doses. Low-dose formulations have shown superior pain reduction and fewer inflammatory reactions, while higher doses have been associated with increased joint swelling in some trials.
Clinical and imaging studies suggest improvements in cartilage quality and thickness, particularly in knee osteoarthritis. Some evidence indicates UC-MSCs may outperform bone marrow–derived products in cartilage repair outcomes, though long-term regeneration remains an active area of research.
Preclinical and early human data suggest potential benefits when UC-MSCs are used as a surgical augmentation, not as a standalone injection. Evidence for primary injection therapy in rotator cuff tendinopathy remains limited, and outcomes vary by injury type and severity.
Umbilical cord stem cells show promising early results in disc degeneration, with improvements in pain and function reported in small studies. However, clinical evidence is still limited, and large randomized trials are lacking. Stem cell therapy for disc disease remains investigational.
Based on current evidence, candidates may include:
Patients with mild to moderate osteoarthritis
Individuals who have failed conservative treatments such as physical therapy or medications
Patients seeking a non-surgical option with realistic expectations
Advanced joint degeneration or severe cartilage loss may respond less predictably.
Current limitations include:
Small study sizes
Short follow-up periods
Variability in cell preparation and dosing
Lack of large, multicenter placebo-controlled trials
For this reason, treatment decisions should be guided by evidence, transparency, and careful patient selection.
Stem cell therapy works by influencing biologic repair processes rather than providing immediate pain relief. Improvements are typically gradual, with changes reported over weeks to months, and some studies showing continued benefit up to one year.
| NCT ID | Title | Phase | Intervention | Link |
|---|---|---|---|---|
| NCT06608134 | Safety and Feasibility of Umbilical Cord Wharton’s Jelly Allograft Injections for Knee Osteoarthritis | Early Phase 1 | UC Wharton’s Jelly Allograft Intra-articular Injection | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT06608134) |
| NCT03390920 | Evaluation of Outcomes With Umbilical Cord Allograft for Musculoskeletal Conditions | Observational | Umbilical Allograft | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT03390920) |
| NCT04750252 | Safety and Tolerability of StroMel™ in Subjects with Moderate to Severe Osteoarthritis of the Knee Joint | Phase 1/2 | StroMel (UC-MSC product) | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04750252) |
| NCT ID | Title | Phase | Intervention | Link |
|---|---|---|---|---|
| NCT04368806 | Efficacy and Safety of JointStem in Patients with Knee Osteoarthritis | Phase 2b/3a | JointStem (adipose-derived MSCs) | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04368806) |
| NCT04440189 | Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis | Phase 3 | GID SVF-2 Device System | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04440189) |
| NCT03203330 | Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee | Phase 3 | TG-C (cell therapy) | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT03203330) |
| NCT04716803 | Bone Marrow Aspirate Concentrate (BMAC) Treatment for Knee Osteoarthritis | N/A | BMAC vs. PRP | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04716803) |
| NCT03477942 | Impact of Mesenchymal Stem Cells in Knee Osteoarthritis | Phase 1 | Autologous MSCs | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT03477942) |
| NCT06463132 | PEP and EUFLEXXA for Knee Osteoarthritis | Phase 1b | PEP/Euflexxa | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT06463132) |
| NCT05835895 | Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis | Phase 1 | GNSC-001 | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT05835895) |
| NCT04238143 | Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis | N/A | tSVF, cSVF, PRP | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04238143) |
| NCT02844751 | Safety Effectiveness of Autologous Regenerative Cell Therapy on Pain Inflammation of Osteoarthritis of the Knee | Phase 2 | StroMed + PRP | [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT02844751) |
| NCT06828666 | Safety and Efficacy of Adipose Tissue Allograft (BRC-OA) in Patients With Osteoarthritis of the Knee | Phase 1/2a | Cryopreserved Adipose Tissue Allograft | [ClinicalTrials.gov](https://clinicaltrials.g |
This page summarizes current evidence and does not replace individualized medical advice. Treatment recommendations at Intercoastal Health are based on clinical evaluation, patient history, and appropriate risk–benefit discussion.
If you’re considering stem cell therapy, the first step is a comprehensive regenerative medicine evaluation to assess your symptoms, musculoskeletal findings, prior imaging (when available), and overall clinical context to determine whether stem cell therapy is an appropriate option.
Individualized care • Clinician-led • Evidence-informed treatment
At Intercoastal Health Jacksonville, Florida, we provide an evidence-informed, patient-centered approach to investigational stem cell therapies. Our focus is on education, ethical decision-making, and individualized care—not experimental treatment without context.
Alongside stem cell consultations, we offer PRP therapy, prolotherapy, regenerative medicine, exosome therapy among our sports injury management. We also offer hormone replacement therapy, longevity medicine, peptide therapy, and injury-focused medical care—supporting informed, clinician-guided choices for patients throughout Northeast Florida.
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3874 San Jose Park Drive
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