Frequently Asked Questions
Frequently Asked Questions
We believe informed patients make better decisions. These are the questions we hear most often — answered honestly, without spin.
Section 1: Regulatory
Is WJ-MSC therapy FDA-approved?
No. WJ-MSC therapy is investigational. The FDA has not approved it for any specific condition. It is currently administered under FDA enforcement discretion guidelines for certain minimally manipulated, same-day-use cellular therapies (21 CFR Part 1271, Section 361 HCT/P framework). This means the results are promising and the science is sound — but the large-scale randomized controlled trials required for formal FDA approval have not yet been completed. We will not tell you otherwise.
Why do you offer an investigational therapy?
Because the science is sound, the safety profile is well-documented, and early clinical results are compelling. Patients who have exhausted conventional options deserve access to promising treatments while the evidence base continues to develop. We are transparent about what is proven and what is still being studied. We track our outcomes, cite our sources, and participate in advancing the evidence — rather than waiting for approval before helping patients who need options now.
What is the difference between investigational and experimental?
“Experimental” implies unproven and potentially unsafe. “Investigational” means the therapy has a scientific rationale, published safety data, and promising efficacy results — but has not yet completed the full FDA approval pathway. WJ-MSC therapy has been studied in hundreds of peer-reviewed clinical trials. It is investigational, not experimental.
Section 2: Safety
What are the side effects?
Common side effects are mild and temporary: soreness, swelling, or bruising at the injection site, typically resolving within 2–5 days. Some patients experience temporary fatigue or a brief increase in pain before improvement begins — this reflects the initial inflammatory response and is normal. Serious adverse events are rare. We track all outcomes systematically and have not observed serious adverse events in our patient population. If you experience fever above 101°F, spreading redness, or signs of infection following treatment, contact us immediately.
Can stem cells cause cancer?
No. This is one of the most common concerns we hear, and it is important to address directly. WJ-MSCs are not immortal cells — they have a finite replication capacity and do not exhibit the uncontrolled proliferation that characterizes cancer. Decades of clinical use in bone marrow transplantation and hundreds of MSC clinical trials have not demonstrated a causal link between MSC therapy and cancer development. We do not treat patients with active cancer or recent cancer history for unrelated reasons — not because MSCs cause cancer, but because the interaction between MSCs and active malignancy is not yet fully characterized.
What if I have a rejection response?
WJ-MSCs are allogeneic — meaning they come from a donor, not from you. However, they have uniquely low immunogenicity compared to other allogeneic cell types. They express low levels of MHC class II antigens and actively suppress immune activation through IDO and PGE2 secretion. Clinically significant rejection responses are extremely rare. We monitor all patients post-treatment and have protocols in place to manage any adverse immune response should one occur.
Are the donor cells screened for infectious disease?
Yes. All donor mothers undergo comprehensive infectious disease screening per FDA requirements: HIV-1/2, HBV, HCV, CMV, HTLV-I/II, syphilis, and additional pathogens. Cells are processed in cGMP-compliant facilities with full sterility testing. No lot is released without a clean sterility report.
Section 3: Effectiveness
Does it actually work?
For many patients, yes — meaningfully. Results vary by condition, disease severity, patient health status, and timing of intervention. The published clinical literature shows consistent improvement in pain scores, functional outcomes, and quality of life across musculoskeletal, autoimmune, neurological, and wound healing conditions. Not every patient responds equally, and we will not promise outcomes we cannot guarantee. What we can tell you is that the mechanism is well-understood, the safety profile is favorable, and the evidence base is growing. We discuss realistic, condition-specific expectations during every consultation.
How long do results last?
Typically 1–3 years for most conditions, depending on disease severity and the patient’s overall health. Some patients experience permanent or near-permanent improvement. Others benefit from re-treatment at 12–18 months as the therapeutic effect begins to wane. Unlike cortisone injections (which wear off in weeks), the structural changes produced by WJ-MSC therapy are built into the tissue — making them inherently more durable. We track outcomes at 1, 3, 6, and 12 months and make re-treatment recommendations based on data, not a fixed schedule.
What if it doesn’t work for me?
We track every patient’s outcomes systematically. If you have not experienced meaningful improvement by 6 months, we schedule a dedicated review consultation to discuss what we observed, what the data shows, and what options remain. This may include re-treatment, referral to a specialist, or a different therapeutic approach. We do not consider a non-response a closed case — we consider it information that guides the next step.
Section 4: Cost & Insurance
How much does treatment cost?
Treatment costs vary based on condition, complexity, delivery method, and cell dose. [INSERT PRICING RANGE IF AVAILABLE — e.g., “Treatment ranges from $X,XXX to $XX,XXX depending on protocol.”] We discuss all costs transparently during your consultation before any commitment is made. We do not have hidden fees. You will know exactly what you are paying for and why before you proceed.
Does insurance cover WJ-MSC therapy?
Most private insurance plans do not cover investigational therapies. Medicare and Medicaid do not cover WJ-MSC therapy at this time. We discuss payment options, financing availability, and cost structure during your consultation. We will never pressure you toward treatment you cannot afford — and we will tell you honestly if the cost-benefit calculation does not make sense for your situation.
Are there financing options?
[INSERT: Financing options if available — e.g., CareCredit, in-house payment plans, etc.] We discuss all available options during consultation.
Section 5: Comparisons
How does this compare to PRP (Platelet-Rich Plasma)?
PRP uses concentrated platelets from your own blood to deliver growth factors to a target tissue. It is a well-established, FDA-cleared procedure for certain applications. WJ-MSCs are living cells with a far broader and more potent secretome — they secrete growth factors, cytokines, extracellular vesicles, and immunomodulatory signals that PRP cannot replicate. PRP is appropriate for mild-to-moderate conditions and has a strong evidence base for certain tendon and joint applications. WJ-MSC therapy is appropriate for more complex, systemic, or advanced conditions where PRP’s mechanism is insufficient. They are not competing therapies — they address different levels of pathology.
Is this better than surgery?
Not necessarily better — different. Surgery addresses structural problems mechanically. WJ-MSC therapy addresses biological problems at the cellular level. For many patients, WJ-MSC therapy is a reasonable first step before committing to surgery — particularly for conditions like knee OA, disc disease, and tendinopathy where surgery carries significant risk and recovery burden. Some patients who pursue WJ-MSC therapy avoid surgery entirely. Others still require surgery later. We will tell you honestly which category we think you fall into based on your imaging and clinical picture.
Why not use my own (autologous) stem cells?
Autologous stem cells — harvested from your own bone marrow or fat tissue — have the advantage of being your own cells, eliminating any immunogenicity concern. However, they carry significant disadvantages: they are as old as you are, carrying the accumulated epigenetic damage, oxidative stress, and reduced replication capacity of your biological age. The harvest procedure (bone marrow aspiration or liposuction) is invasive and adds procedural risk. And the yield is limited — you cannot scale autologous cells to therapeutic doses without extensive culture expansion. WJ-MSCs start at biological zero, are available in consistent therapeutic doses, and have demonstrated superior potency in head-to-head comparisons. For most patients, WJ-MSCs are the superior choice.
Section 6: Lifestyle & Activity
When can I return to sports or exercise?
This depends on your condition, the delivery method used, and your individual healing response. As a general guideline: light activity and walking resume at 2 weeks, moderate exercise at 4–6 weeks, and full sport or high-impact activity at 8–12 weeks. We provide individualized activity guidelines at discharge and adjust them based on your progress at follow-up appointments. Returning to activity too early is one of the most common reasons for suboptimal outcomes — we take this guidance seriously.
Will I have restrictions on activity after treatment?
Yes, initially. The first 2 weeks require relative rest — avoiding high-impact activity, heavy resistance training, and significant loading of the treated area. This is not optional — it protects the healing environment during the critical early paracrine signaling phase. After 2 weeks, activity is gradually reintroduced based on your response. We provide written activity guidelines at discharge and are available to answer questions about specific activities during your recovery.
Do I need to change my diet or lifestyle?
We recommend an anti-inflammatory lifestyle to support and extend the therapeutic benefit: a whole-food, low-processed diet, regular low-impact movement, adequate sleep, and stress management. Smoking significantly impairs healing and is a relative contraindication to treatment — we ask patients to quit before and during the treatment window. Alcohol should be avoided for 72 hours post-treatment. These are not arbitrary restrictions — they directly affect the biological environment in which healing occurs.
Section 7: Special Populations
Can I receive treatment if I am pregnant?
No. We do not administer WJ-MSC therapy during pregnancy. The safety of allogeneic cell therapy during pregnancy has not been established, and we will not proceed without that data. If you are planning pregnancy, discuss timing with Melissa and your OB/GYN. Treatment is typically recommended to be completed well before conception or deferred until after delivery and breastfeeding.
What if I have a history of cancer?
Cancer history is evaluated on a case-by-case basis. Active cancer is an absolute contraindication. For patients in remission, the evaluation considers cancer type, time since remission, current immune status, and the condition being treated. We consult with your oncologist before proceeding in any case with cancer history. We will not treat a cancer history patient without oncology clearance.
Can I receive treatment if I take blood thinners?
Yes, in most cases — with precautions. Blood thinners (anticoagulants and antiplatelets) increase bleeding risk at the injection site. We review all medications during your consultation and provide specific guidance on whether to hold, adjust, or continue your blood thinner around the treatment date. This decision is made in coordination with the prescribing physician. Never stop a blood thinner without physician guidance.
What about elderly patients?
Age alone is not a contraindication. We have treated patients in their 70s and 80s with excellent outcomes. The relevant factors are overall health status, disease severity, and realistic goals — not chronological age. WJ-MSCs are particularly well-suited for older patients because their Age Zero quality is independent of the patient’s biological age.
Section 8: Skepticism & Due Diligence
How do I know this isn’t a scam?
This is exactly the right question to ask — and the fact that you are asking it is a good sign. Here are the red flags that distinguish predatory stem cell clinics from legitimate regenerative medicine practices:
- ✗ No physician on staff or physician not directly involved in treatment
- ✗ Guaranteed cures or promises of specific outcomes
- ✗ Pressure to pay large sums upfront before consultation
- ✗ No outcome tracking or refusal to share outcome data
- ✗ “Secret proprietary methods” with no published protocols
- ✗ Claims to treat any condition with the same protocol
- ✗ No discussion of FDA status or regulatory framework
- ✗ Discourages second opinions or consultation with your existing physicians
At Kelton Komprehensive: Melissa personally conducts every consultation and oversees every treatment. We do not guarantee outcomes. We discuss costs transparently before any commitment. We track and share outcome data. We publish our protocols and cite peer-reviewed research. We tell patients honestly when they are not a good fit. We encourage second opinions. We discuss FDA status on this website, in consultation, and in our informed consent documentation.
Can stem cells cure my condition?
Cure is rare. Meaningful, durable improvement is common. We do not use the word “cure” because it sets an expectation that the evidence does not consistently support. What the evidence does support is significant pain reduction, improved function, slowed disease progression, and improved quality of life for the majority of appropriate candidates. We discuss realistic, condition-specific expectations during every consultation — and we will tell you honestly if we think the probability of meaningful benefit for your specific situation is low.
Should I get a second opinion before proceeding?
Yes. We actively encourage it. Discuss this therapy with your primary care physician, your specialist, and any other trusted medical advisor. Bring the research we cite on our Clinical Evidence page. Ask hard questions. A legitimate regenerative medicine practice welcomes scrutiny — it is the predatory ones that discourage it.
Still Have Questions?
If your question isn’t answered here, we want to hear it. Schedule a free consultation and ask Melissa directly — no pressure, no commitment, just an honest conversation.