Celva Bio / Treatments / Systemic & complex conditions
§ 003 / Treatment · Evaluation-first

We'll tell you
honestly if this
can help.

Systemic and complex-condition programs are the most consequential work we do. And the most uncertain. We run a long evaluation before we treat, and we decline more applicants than we accept. If we think the honest answer is "not this therapy," we will say so.

Acceptance
44%
of inquiries accepted for treatment
Evaluation
2–3 wk
Multi-disciplinary review, before any commitment
Baseline
12+
Functional measures captured before dose one
Two Celva clinicians reviewing brain MRI slices on a monitor during a multi-disciplinary case review
FIG. 03 · Multi-disciplinary review Specialty + regenerative, together
§ 003.1 / What we tell you first

Systemic & complex cell therapy
is real, partial, and
still being understood.

There is credible evidence that mesenchymal stem cells can modulate neuroinflammation and, in specific conditions, support function. There is not yet credible evidence that they reverse established neurodegeneration, regrow myelin at scale, or restore lost neurons in a clinically meaningful way.

We operate in the window between those two statements. For some patients (with the right condition, the right disease stage, and realistic expectations) that window is worth entering. For many, it isn't.

Everything below is written assuming you want the real picture, not the marketing one.

§ 003.2 / Candidacy

Conditions we consider.
And ones we don't.

We do not treat every diagnosis we're asked about. Below is where we believe the current evidence supports cautious intervention, and where it clearly does not. This list grows as data matures across autoimmune, neurologic, and cardiovascular indications.

Consider · case-by-case

We may accept

CNS · inflammatory

Relapsing-remitting MS (select cases)

Stable disease-modifying therapy, documented active inflammation, treating neurologist willing to co-manage. Not a DMT replacement. A potential adjunct.

Stage
Early / active
Likelihood
Low–moderate
PNS · post-viral

Post-COVID small-fiber neuropathy

Biopsy or QSART-confirmed, symptoms < 24 months, failed standard care. We have modest but consistent signal here, across patient-reported and autonomic testing.

Stage
Subacute
Likelihood
Moderate
Autonomic

POTS & dysautonomia (inflammatory)

Post-infectious or autoimmune phenotype, failed tilt-table directed therapy. We stratify aggressively. The label covers very different biology.

Stage
Any
Likelihood
Low–moderate
CNS · vascular

Chronic post-stroke deficit

6–36 months post-event, plateaued on standard rehab, stable imaging. Modest functional signal in distal limb control for a subset of patients.

Stage
Chronic / plateaued
Likelihood
Low
Decline · as of 2026

We do not accept

Motor-neuron

Late-stage ALS / MND

We decline late-stage applicants where structural loss is advanced. Evidence does not support meaningful functional benefit at that stage. Early-to-mid ALS is considered separately, for quality-of-life support only, never framed as disease-modifying or a cure.

Cortical · advanced

Advanced Alzheimer's or FTD

No current protocol can restore established cortical loss. Early-stage, well-characterized patients are occasionally considered in research contexts only. Never as a billed treatment.

Spinal · acute

Acute spinal-cord injury

Acute SCI belongs in trial protocols at Level-1 centers, not in a private clinic. Chronic cases > 12 months post-event, with stable imaging, we discuss. Individually, skeptically.

Unrealistic expectation

"Regrow brain" requests

We will not sell hope that isn't supported. If the intake form describes expected outcomes we know are unreachable with current cell therapy, we end the process there. Candidly.

§ 003.25 / Mechanism · systemic

How the cells
work systemically.

For systemic and complex indications the goal is to recalibrate the upstream biology — chronic inflammation, dysregulated immune activity, compromised perfusion, neuroinflammation where present — so the body's own repair machinery can function again. The signaling persists well beyond the cells themselves.

How the cells work — four simultaneous mechanisms

Anti-inflammatory

Suppresses the chronic inflammatory signaling driving pain, dysfunction, and progressive tissue damage — systemically.

Anti-fibrotic

Interrupts the fibrotic cascade that replaces functional tissue with scar, a downstream consequence of chronic inflammation.

Immunomodulatory

Recalibrates dysregulated immune activity across the body without systemic immune suppression.

Pro-angiogenic

Supports formation of new vascular networks, improving tissue perfusion and creating a more favorable systemic repair environment.

§ 003.3 / Evaluation

A 2–3 week evaluation,
before any decision.

Systemic and complex cases demand more than a blood panel and a consult. Every applicant we take past intake goes through a multi-disciplinary review. We say yes, no, or "come back when X changes." We'll tell you which.

  1. 01
    Week 0 · day 1–2

    Intake & records

    Full medical history, imaging, neurology notes, prior treatment trials. We need everything, including what didn't work.

  2. 02
    Week 1

    Coordinator intake & physician team review

    45-minute call with a Celva patient coordinator. The physician team in Mexico then reviews independently — focused on disease stage, medication stability, and whether the evaluation should proceed. Not a sales call.

  3. 03
    Week 2

    Multi-disciplinary review

    Each case is reviewed by the physician team's regenerative attending with outside specialty consultation (neurology, rheumatology, cardiology, or other as relevant) and, where appropriate, PM&R review. Multiple opinions inform every decision.

  4. 04
    Week 2–3

    Baseline capture

    If we're considering acceptance: functional testing, autonomic battery, disease-specific scales (EDSS, COMPASS-31, Fugl-Meyer, etc.). Captured before any decision is finalized.

  5. 05
    Week 3

    Decision & plan

    One of three outcomes, in writing:
    Accept, with a specific protocol, expected magnitude, and measurement plan.
    Decline, with the reason, and any referrals we can make.
    Revisit, with the conditions under which we would re-open the case.

How selective we are

Systemic & complex cohort

We are selective in patient acceptance and only move forward when a case appears clinically appropriate and expectations are realistic. Each application moves through intake, records screen, multi-disciplinary panel review, and a written plan. Cases that don't fit are declined in writing, with a referral when one is available.

§ 003.4 / Protocol (if accepted)

What treatment
looks like, for accepted patients.

Systemic and complex protocols are tailored. Dose, route, and cadence depend on condition and disease stage. Below is the common architecture. Specifics live in your written plan.

Source
Allogeneic UC-MSCs, P3 expansion
Typical dose
100–300M cells per session
Delivery
IV (intrathecal case-by-case after physician review)
Sessions
3 over 12 months
Re-evaluation
Every 90 days
Co-management
Required with treating specialist
Exit criteria
Pre-defined, written
01 / Dose one

First treatment & observation

IV (and IT where indicated) under attending supervision. Short inpatient window for intrathecal cases. Functional re-test at day 14 and day 45.

1–2 nights on site · post-dose labs included
02 / 90-day gate

First decision point

We re-run your functional battery and compare to baseline. If the delta is below our pre-agreed floor, we pause. No automatic dose two.

Written assessment · accept / pause / stop
03 / Dose two

If signal is present

Second treatment at 4–6 months. Dose adjusted on response. Same observation protocol, same re-test cadence.

Conditional on gate 01
04 / 180-day gate

Second decision point

Repeat full battery. The question we answer: is continuation doing something we can defend in writing? If not, we stop and say so.

Written assessment · shared with your neurologist
05 / Dose three + exit

Consolidation & handoff

Final treatment for responders. Comprehensive handoff package to your treating neurologist: all data, all trajectories, everything we'd want if we were on their end of the chart.

Month 10–12 · handoff document delivered
§ 003.5 / A case we declined
"I wanted so badly to accept him. He'd already flown to four clinics. What he needed, what would have been honest, was hospice planning and time with his family. We said so. He thanked us. That's the one I think about."
Dr. Alejandro Castillo, MD
Regenerative medicine attending · physician team
Declined · 2024
43
Declined · 2025 (YTD)
51
Accepted · same period
94
Most common reason
Disease stage too advanced
§ 003.6 / Fit

Before you apply,
a self-check.

We would rather lose an application at this stage than at the written-decline stage four weeks later.

Likely a fit

You might be
right for this.

  • You have a specific diagnosis, on the conditions list above, with imaging and records to match.
  • You are stable on disease-modifying therapy and have a neurologist willing to co-manage.
  • You understand this is unlikely to be curative, and you are choosing to try anyway, eyes open.
  • You can commit to a 12-month measurement plan, including two in-person re-evaluations.
  • You want a clinic that will tell you to stop if the data says to stop.
Likely not

This probably
isn't for you.

  • You have been told by multiple clinicians that your condition is terminal and near end-stage.
  • You're looking for a protocol to reverse established neurodegeneration or regrow cortex.
  • Your treating physicians are unaware of this consultation.
  • You cannot return for re-evaluation or coordinate ongoing care locally.
  • You are looking for certainty, and cannot operate inside a response rate that is meaningfully less than complete.
§ 003.7 / Next step

Every program is
built case by case.

Systemic and complex cases are never standard. The plan is designed only after the physician team's review.

There is no fixed protocol for this track. Depending on your case, the team may recommend a single diagnostic dose with a 90-day re-evaluation, or a structured multi-dose protocol with quarterly re-measurement and a written handoff to your treating specialist. That decision is made from your records, not in advance.

And the team can stop. If the data at the first 90-day decision point doesn't support continuing, they pause the program and tell you plainly. We want that decision to be easy for us to make.

Start an intake and a Celva patient coordinator gathers your case for the physician team's independent review. Nothing is scheduled until that review is complete and you have decided to move forward.

Start your intake →
§ 003.8 / Dig deeper

Track-specific
reading.

For patients and families who want the detailed read on candidacy, expectations, and how the evaluation actually works. One page per topic.

§ 003.9 / Questions

Track-specific
questions.

Q.01 Why are you so selective about who you accept?
Because the biology here is harder — neuroinflammation, autoimmunity, post-viral states, vascular disease — and the harm of selling false hope is measured in a family's time, energy, and trust. Even among carefully chosen patients, not everyone responds. Accepting everyone who wanted treatment would erode the honesty of our outcomes, and the trust patients place in our accepting them.
Q.02 What does "intrathecal delivery" mean, and is it required?
Intrathecal means injection into the cerebrospinal fluid through a lumbar puncture. It puts the cells closer to the CNS than IV alone. For some CNS conditions we recommend it; for peripheral or autonomic conditions, IV alone is appropriate. The decision is part of your written plan, not a pre-sold add-on.
Q.03 Do you coordinate with my specialist?
Yes. Co-management is required, not optional — whether your specialist is a neurologist, rheumatologist, cardiologist, or other. If your treating physician is unwilling to be looped in, we will not take the case. Every handoff document is designed to be the kind of record we'd want to receive if we were the one managing you long-term.
Q.04 What happens if nothing measurable changes in my first 90 days?
We stop. You receive a written summary of what we measured, what we expected, and what we observed, and we do not proceed with further dosing. The second dose is conditional on meeting the pre-agreed response floor, written into your plan before dose one. Exactly to prevent the dynamic where a clinic keeps dosing a non-responder.
Q.05 Is this a clinical trial?
No. This is a physician-led treatment program licensed in Mexico and regulated by COFEPRIS. We measure outcomes rigorously and publish them, but we are not an IRB-registered trial site. If a trial exists for your condition at a major center and you might qualify, we'll tell you. Sometimes that's the honest recommendation.
Q.06 What's the downside I should know about?
Three. First: there is a real chance that the treatment does not produce measurable change, and the program may end without the result you hoped for. Second: intrathecal dosing, where it is performed (case-by-case, after physician review, never as a routine offer), carries the standard LP risk profile (headache, rare bleeding, very rare infection). Third: unlike joint patients, systemic and complex patients often face the slow, ambiguous grief of "did it work?" We structure measurement to cut through that. Not every patient wants that level of cold clarity, and it matters to know that going in.
§ 003.10 · Apply

Start with
the evaluation.

Not a sales call. A records review, a screen, and a multi-disciplinary opinion. If we accept you, we'll tell you what to expect. In writing. If we don't, we'll tell you why, and where we think you should look next.

Start your intake →
These therapies are not FDA-approved. Treatments are performed in Mexico by the physician team at Hospital Angeles, Tijuana, regulated by COFEPRIS. Individual results may vary. Not medical advice. All patients undergo rigorous screening before treatment is recommended.