Medically reviewed by the Celva medical team · June 2026

§ 1.3 · Section 1 · Why leave the United States?

Clinical trials vs. treatment abroad.

A decision aid for the patient who knows there are U.S. trials for their condition and is trying to figure out whether to wait for one, apply to one, or pay for treatment in Mexico.

Prefer to watch?

Trials or treatment, the honest trade-off.

This page is an 11-minute read. The video walks the same decision: what a U.S. trial asks of you, what treatment abroad offers in return, and how to choose between them. Keep scrolling for the full version.

Rather read? The full breakdown continues below
§ 1.3 · trials vs treatment
U.S. trial pathFree · waitlist
7–12 yr horizon
351/361
Treatment abroadPaid · scheduled
weeks, not years

Same cells, different rooms. The trade is time vs. money and the honest comparison lives in the columns of the table below.

The same cells. Very different rooms.

Roughly 1,200 stem-cell trials are active worldwide as of 2025. Several hundred of them are U.S.-based. Many recruit for conditions a patient considering treatment in Mexico is also thinking about: MS, Crohn's, lupus, knee OA, certain cardiomyopathies. The cells used in those trials are often structurally indistinguishable from the cells used at a place like ours: same source tissue, same expansion protocol, same release tests. So why isn't the answer always "do the trial"?

Because the trial is a different product. The cells may be the same; the experience is not. A trial is a research instrument first and a treatment second, its job is to generate generalizable knowledge, and almost every constraint follows from that. A paid treatment is the opposite: its job is to deliver care to one specific patient, and almost every constraint follows from that. Same intervention, different goals, different rules. This page makes the trade-off explicit.

§ Time-to-infusion

~14 mo vs. 2–6 wk.

Median elapsed time from first contact to actually receiving cells, U.S. trial vs. Celva.

§ Eligibility funnel

3–8% qualify.

Of patients who screen for a typical phase-2 MSC trial, ~3–8% meet all inclusion + exclusion criteria.

§ Cost & certainty

Free / 50% or paid / 100%.

Trial: no charge to the patient, but a randomized trial gives you a 50% chance of placebo. Celva: paid out of pocket, but you receive cells.

Frame 01§Two different products

It is not the same cells in two settings.

The first move when comparing these is to drop the assumption that they're variants of the same thing. They aren't. A clinical trial is structured to answer a question for thousands of future patients. A paid treatment is structured to deliver an intervention to the patient sitting in the chair today. Almost every difference downstream: eligibility, randomization, cost, follow-up, what gets reported, falls out of that one distinction.

Figure 1.3.1 · Two products, side by side
Path A · U.S. clinical trial

A research instrument.

Designed to test a hypothesis. Run by a sponsor (NIH, biotech, academic center). Patients are subjects; cells are the experimental intervention; outcomes feed regulatory submissions.

FundingSponsor
Patient costNo charge
Outcome ownerFDA / sponsor
You may getPlacebo
Path B · Treatment abroad

A clinical service.

Designed to deliver an intervention to one patient. Run by a clinic. The patient is the paying party; cells are a product; outcomes are tracked for that patient's record.

FundingPatient
Patient costOut of pocket
Outcome ownerPatient
You will getCells

One reading of this is that the trial is the higher-integrity choice: it contributes to knowledge, it's free, it's under FDA supervision. That reading is half right. The other half is: a trial is not a treatment plan. The trial's job ends when its data is submitted. If the cells worked for you specifically, the trial doesn't follow you into year three. If they didn't, the trial doesn't compensate you for the year you spent in placebo. The trial's accountability is to the question, not to you.

Matrix 02Twelve dimensions head-to-head

The structural deltas, line by line.

What follows is a careful reading. Each row is a real difference that bites at some point in the patient experience. Some favor the trial. Some favor treatment abroad. The honest answer is that no single column wins, the question is which row matters most for your situation.

Figure 1.3.2 · Twelve dimensions compared
Dimension
U.S. clinical trial
Treatment abroad (Celva model)
Cost to patient
No charge to the patientTrial pays for the intervention, screening, sometimes travel. You may pay incidental costs (parking, time off work).
Paid out of pocketYou pay the clinic directly. Insurance does not reimburse. HSA/FSA may cover part.
Eligibility
NarrowStrict inclusion/exclusion: age, disease severity, prior treatments, comorbidities. ~3–8% of screeners qualify.
Broader, but not unlimitedMost inquiries that pass screening are treated; a meaningful share are declined for safety or expectation reasons. See §4.5.
Randomization
Usually yesMost phase-2/3 trials randomize 1:1, 50% chance of placebo or active comparator, not the experimental cells.
NeverYou receive cells. No randomization, no blinding, no placebo arm.
Cell product
One specific productThe trial's product, often allogeneic UC-MSC or BM-MSC, manufactured at a specific cGMP facility. Dose fixed by protocol.
Our productAllogeneic UC-MSC, manufactured in-house. Dose tailored within an indication range. See §3.5.
Time to infusion
~12–18 monthsIdentify trial → screening (3–6 mo) → enrollment → randomization → first infusion. Plus the wait for the trial to be open.
~4–8 weeksIntake → records review → consult → physician sign-off → scheduling → infusion. See §5.1.
Follow-up
Extensive, time-limitedPer protocol: often 12 or 24 months of structured visits, imaging, labs. Then the trial ends and follow-up stops.
Lighter, indefiniteWeek 1, then months 1, 3, 5, 9, and 12 by phone/video. No formal endpoint. Your local doctor remains primary.
Safety oversight
IRB, DSMB, FDAThree layers. Adverse events reportable. Trial can be halted by any of them. Strongest patient-safety apparatus in medicine.
COFEPRIS + hospital quality committeeMexican regulator + hospital-level review. See §4.4. Strong but not equivalent to trial oversight.
Geography
Often distantU.S. trials concentrate at academic centers: Boston, Houston, Cleveland, Stanford. May require relocation or repeat travel.
Single dayOne day-trip to Tijuana. Most patients fly home to San Diego the evening of treatment. See §5.1.
What's "approved" downstream
Whatever you gotIf the trial drug is later approved, you may have priority access. If the trial fails, the drug is gone.
Not regulated for U.S. approvalThis is a commercial service, not a path toward FDA approval. The intervention exists only in the country it was delivered.
Re-treatment
Not on protocolYou receive the protocol-specified doses. Re-treatment outside the trial is not the trial's concern.
Possible, paidPatients who respond may return for additional infusions at additional cost. Not all clinics offer this honestly.
Contribution to science
DirectYour data feeds the trial; the trial feeds the field. This is the real ethical pull of the trial path.
MinimalOutcomes data exists in your chart but does not aggregate into peer-reviewed evidence. We say this plainly; see §6.4.
What the result feels like
Bigger meaning, smaller chanceIf it works, you helped prove it works. If it doesn't, you were part of finding that out. Either way, an answer.
Personal stake, no big "result"You either benefited or you didn't. The cells worked for you or they didn't. No external finding to point at.
Funnel 03%Who actually qualifies

The eligibility number is the one most patients miss.

The most common pattern we see is a patient who reads about an active trial, gets excited, and assumes "active recruitment" means "available to them." It rarely does. Trials are designed to test the intervention in a clean population: which means almost every comorbidity, prior treatment, or unusual lab value is a reason to exclude you. The numbers below are a representative funnel for a mid-stage MSC trial in autoimmune disease. They are not Celva's numbers; they're industry typical.

Figure 1.3.3 · The eligibility funnel for a typical phase-2 MSC trial

Of 100 patients who hear about the trial, about 5 enroll.

Heard about the trialSelf-referral or clinician
100
100baseline
Passed phone screenAge, diagnosis, geography
60
60−40 dropped
Records review passedDisease severity in window
32
32−28 dropped
On-site screening passedLabs, imaging, comorbidities
14
14−18 dropped
Consented + enrolledSigned ICF; randomized
6
6≈6% of original
Received the actual cells1:1 randomization
3
350% got placebo

The dropoff happens at every stage and the dropoff has a structure. The phone-screen losses are usually geography and rough diagnosis. The records-review losses are disease severity (too mild or too severe, trials want the middle). The on-site losses are comorbidities (kidney disease, prior cancer, heart failure, recent surgery, all common, all disqualifying). The randomization halves whatever's left. Of the original 100 patients who started the process, 3 will actually receive the experimental cells. If you've heard "I tried to get into a trial and it didn't work out". this funnel is why.

Time 04How long it actually takes

Fourteen months vs. two to six weeks.

Time is the second variable patients underestimate. The trial timeline is dominated by waiting: for screening slots, for randomization, for the trial to open at a center near you. The treatment-abroad timeline is dominated by preparation: records review, financing, travel arrangements. Both are real work, but they live on completely different clocks.

Figure 1.3.4 · Elapsed time, first contact to infusion

Same patient, two timelines.

Path A. U.S. clinical trial
Find & contact
Screening
Wait for slot
Enroll → infusion
M0
M3
M6
M10
M14
Median elapsed~14 months from first email to first infusion
Path B. Treatment abroad (Celva)
Intake call
Records review
Consult & quote
Travel + infusion
W0
W1.5
W3
W4.5
W6
Typical range2–6 weeks from first email to first infusion

Patients with progressive disease: MS that's actively flaring, RA that's failing biologics, autoimmune neuropathy losing function quarter over quarter, are the population for whom this delta is decisive. A year in the trial waiting room is a year of disease progression. A two-to-six-week window is a different cost-benefit calculation. This is not an argument that the trial is wrong; it is an argument that the trial is slow. If you have time, the trial's slowness is fine. If you don't, it isn't.

Outcome 05§What you actually walk away with

What each path leaves you holding.

The simplest way to think about this is to imagine yourself eighteen months from now and ask: what do I have? The answer is genuinely different in each column. A trial leaves you with a structured experience, a contribution to science, and either a strong response or a placebo. A paid treatment leaves you with cells in your bloodstream, a thinner data record, and ownership of whatever happens next.

Figure 1.3.5 · What you walk away with at month 18

The deliverables, plainly listed.

Path A. U.S. clinical trial
  • +
    No charge to the patient. No medical bill, no flight, no hotel. (Time off work is on you.)
  • ±
    50% chance you got the cells. 50% chance you got placebo or active comparator.
  • +
    The strongest safety monitoring in medicine. IRB, DSMB, FDA all reviewing your case.
  • +
    A data record of unusual depth. Labs and PROs at every protocol-specified visit, imaging on the cadence your case calls for.
  • +
    Contribution to the published literature. Your outcomes (anonymized) feed the trial's paper.
  • No personalization. Dose, timing, and follow-up are fixed by protocol, not by you.
  • ~14 months of your life. Most of it spent waiting and being screened.
Path B. Treatment abroad (Celva)
  • Paid out of pocket by the patient. HSA/FSA may cover part; no insurance reimbursement.
  • +
    100% chance you received cells. No randomization, no placebo arm.
  • ±
    Strong but not trial-equivalent safety. COFEPRIS + hospital QC; not FDA.
  • ±
    A thinner data record. Pre-infusion baseline, then week 1 and months 1, 3, 5, 9, and 12. No imaging cadence.
  • No contribution to published literature. Your outcomes stay in your chart.
  • +
    Personalization within range. Dose tailored to indication; re-treatment possible.
  • +
    One day at the hospital. 2–6 weeks from first call to scheduled infusion; the treatment itself is a single day, San Diego by evening.
Decide 06?A decision tree

Four questions, in this order.

If you're trying to choose, these are the four questions in the order that actually narrows the field. Earlier questions are dispositive, getting "no" on Q1 ends the discussion. The verdict at the bottom is what we'd tell a friend, not a recommendation to the public.

Figure 1.3.6 · Four questions, in order

What to ask yourself, top to bottom.

Question 1 · Eligibility

Is there an actively recruiting trial for your specific indication, and do you meet its inclusion criteria?

If yes →

Go to Q2. ClinicalTrials.gov is the search; your local academic center is the next call.

If no →

The trial path is closed. The question collapses to: paid treatment abroad, or no treatment. Skip to Q4.

Question 2 · Time

Can your condition tolerate 12–18 months from now to first infusion?

If yes →

The trial is the higher-integrity choice. Go to Q3 to stress-test it.

If no →

Progressive disease, age, or quality-of-life decline make the wait costly. The faster path becomes proportionally more defensible.

Question 3 · Randomization

Can you accept a 50% chance of receiving placebo or active comparator instead of the experimental cells?

If yes →

This is the philosophical posture that makes trials work. The trial is the right choice. Apply.

If no →

An honest "I want the cells, not a coin flip" is a legitimate stance. The trial path loses its case.

Question 4 · Cost

If you've decided the trial isn't the path, can you absorb the out-of-pocket cost of the paid alternative without destabilizing your finances?

If yes →

Treatment abroad is a defensible choice. Vet the clinic carefully (§6) and proceed.

If no →

Neither path is right today. Wait, save, or pursue conventional care. We will tell you this in consult if it's what we see.

Trial path wins when

You qualify, you have time, you accept randomization. The trial is then unambiguously the higher-integrity, lower-cost, more-rigorously-monitored choice.

Treatment abroad wins when

You don't qualify, or you do but can't wait, or you can wait but won't accept placebo, and you can absorb the cost. Otherwise neither path is right today.

Honest 07·What we will not claim

Three sentences we won't say.

Some clinics frame this comparison as a slam-dunk for the paid path. We don't, because the framing is dishonest. The trial path has real advantages we cannot match. Three statements we won't make, in any consult or any page on this site:

The lines we will not cross.

  • "Trials are slow because of bureaucracy." Trials are slow because they are structured to generate generalizable, regulator-grade evidence. The slowness is the feature, not the bug. We are faster because we are doing a different, less rigorous thing.
  • "You'd be better off paying than waiting for a placebo." Maybe. But only sometimes, and only for some patients. The phrase that you might hear at a sales-driven clinic, "why gamble on placebo?", pretends that paid treatment has the same evidence base as the trial it's competing against. It doesn't.
  • "Mexico has the same standards." Mexico has different standards. Some are stronger than what U.S. wellness clinics meet (see §6.3). None are equivalent to an FDA-supervised RCT. Anyone telling you otherwise is selling.

If you're a candidate for a trial, the trial is usually the right first call. We tell candidates this in consult, and decline patients who'd be better served by a trial that's actively recruiting for their indication. That isn't generosity; it's how we'd want to be treated.

The bottom line

The cells may be the same. The product isn't.

A trial is a research instrument: no charge to the patient, slow, narrow eligibility, 50% chance of placebo, strongest safety oversight, contributes to science. A paid treatment is a clinical service: paid out of pocket by the patient, fast, broader eligibility, you receive cells, lighter oversight, no scientific contribution. If you qualify and have time and accept randomization, apply to the trial. Otherwise, treatment abroad is defensible if (and only if) you can absorb the cost and vet the clinic. If neither column fits, neither path is right today.