Cell Verification & Lab Standards

Every cell
we use has been
independently verified.

We will show you exactly what we test, who tests it, and what the standards mean. No vague language about "highest quality." Documented evidence — or we don't use the cells.

Dezawa Authorized Healthcare Center — MUSE Cells

Decima is an Authorized Healthcare Center for Dezawa MUSE Cells — the world's only non-tumorigenic pluripotent stem cells in active clinical trials. Authorization requires demonstrated protocol compliance, physician oversight verification, and direct agreement with Regene Global.

Our Standards

What GMP actually means.
And what we require beyond it.

GMP (Good Manufacturing Practice) is the FDA's baseline standard for biological product manufacturing. It covers sterility, potency, identity, and purity. We require GMP as a minimum — and add independent third-party verification on top of every batch.

GMP Certified Manufacturing
All Decima cells are produced in GMP-certified facilities. This means strict documentation, controlled environments, validated processes, and full traceability from donor to patient. GMP certification requires regular facility inspection by regulatory bodies.
Required — all suppliers
Independent Third-Party Testing
Every batch is tested by an independent laboratory before we accept it. Internal testing by the manufacturer alone is not sufficient. We require external verification of viability, sterility, identity, and potency. The certificate of analysis is available to every patient before their treatment.
Required — every batch
Donor Screening Protocol
All donors are screened for communicable diseases (HIV, Hepatitis B and C, CMV, and others) in accordance with FDA 21 CFR Part 1271 standards. We do not accept tissue from donors with incomplete screening documentation.
FDA 21 CFR 1271 compliant
Fresh & Cryopreserved Cell Protocols
Decima offers both fresh (live, never frozen) and cryopreserved (frozen) cell formats for both MUSE cells and Wharton's Jelly MSCs. Fresh cells offer the highest immediate viability and biological activity — ideal when timing allows. Cryopreserved cells offer scheduling flexibility and are available for same-week treatment. Both formats are GMP-certified and independently tested. Your physician selects the format based on your protocol and timeline.
Both formats available · MUSE & MSC
Physician Authorization Required
No cells are ordered until a board-certified physician has reviewed your intake and issued written approval. Cells are matched to your specific protocol by the approving physician, not by administrative staff.
Board-certified physician sign-off
What We Test

Six tests. Every batch.
Before it reaches you.

Cell Viability
What percentage of cells are alive at the time of administration. We require a minimum 99% viability threshold. Batches below this are rejected regardless of other results.
Minimum ≥99% viability required
Sterility
Confirmation that the cell product is free from bacterial, fungal, and mycoplasma contamination. Sterility testing is the most critical safety check in the batch release process.
USP <71> sterility standard
Cell Identity
Confirmation that the cells are what they are claimed to be — MSCs, MUSE cells, or NK cells — using surface marker analysis (flow cytometry). Prevents substitution or contamination with other cell types.
Flow cytometry — ISCT criteria
Cell Count & Dose
Verification that the vial contains the stated number of cells. Cell count is confirmed by an independent laboratory counter, not self-reported by the manufacturer.
Independent hemocytometer count
Endotoxin Testing
Endotoxins are bacterial cell wall components that can cause fever and inflammatory reactions even in sterile products. Endotoxin testing is separate from sterility testing and required for injectable biologics.
LAL test <5 EU/mL
Donor Disease Screening
All donor tissue is tested for HIV-1/2, Hepatitis B and C, HTLV-I/II, CMV, and other communicable diseases per FDA guidelines. Testing certificates accompany every batch.
FDA 21 CFR 1271 & AATB standards
Dezawa MUSE Cells

The only non-tumorigenic
pluripotent stem cell
in clinical use.

MUSE cells — Multilineage Undifferentiated Stem Cells — were discovered by Professor Mari Dezawa at Tohoku University in Japan. They are the only pluripotent stem cells that have been proven non-tumorigenic in clinical trials. Every other pluripotent stem cell type carries tumor formation risk. MUSE cells do not.

Decima is an Authorized Healthcare Center for Dezawa MUSE Cells through Regene Global — one of a small number of practices in the United States authorized to coordinate access to this protocol. Authorization is not automatic. It requires demonstrated physician oversight, protocol compliance, and direct agreement with the licensing organization.

DiscoveredTohoku University, Japan · Prof. Mari Dezawa
Clinical trialsALS, Stroke, Diabetic neuropathy, Spinal cord
Key propertyNon-tumorigenic pluripotency — unique globally
AuthorizationRegene Global · Authorized Healthcare Center
Decima statusAuthorized · Physician-supervised protocols only
Dezawa Authorized Healthcare Center

This authorization badge is issued by Regene Global to healthcare centers that meet their standards for physician oversight, protocol compliance, and patient safety documentation. It is not self-issued.

Supply Chain

From donor
to your door.
Every step documented.

We use a small number of deeply vetted suppliers — not a procurement marketplace. Each supplier relationship involves direct agreements, facility documentation, and ongoing batch-by-batch verification.

1
Donor selection and screening
Tissue is collected from healthy donors following live birth, with full informed consent. Donors are screened for communicable diseases per FDA 21 CFR Part 1271. Donors with incomplete documentation are excluded.
2
GMP manufacturing and cell expansion
Cells are isolated and expanded in GMP-certified cleanroom facilities. Every step is documented with batch records. Manufacturing environment is monitored for particulates and bioburden throughout.
3
Independent third-party testing
Before release, every batch is sent to an independent laboratory for viability, sterility, identity, count, endotoxin, and donor disease screening verification. Batch is held until all tests return passing results.
4
Physician approval and cell selection
Your board-certified physician reviews your intake, selects the appropriate cell type and dose for your specific protocol, and issues written authorization. Cells are ordered only after physician sign-off.
5
Cryogenic shipping with temperature monitoring
Cells ship in validated cryogenic containers with continuous temperature loggers. Shipment temperature records are reviewed before cells are accepted. Any excursion triggers automatic rejection.
6
Administration by trained medical staff
A registered nurse or physician administers the cells at your location. A board-certified physician is available by phone throughout the treatment window. Full adverse event documentation protocol in place.
Common Questions

Honest answers to what
patients actually ask us.

Can I see the certificate of analysis for my specific batch before treatment?
Yes. Every patient receives the certificate of analysis for their specific cell batch before their treatment date. This document shows viability, cell count, sterility results, and donor screening results. If a batch does not have a complete certificate, we do not use it.
Are these the same cells used in clinical trials?
For MUSE cells, yes — Dezawa MUSE cells are the identical cell type used in clinical trials for ALS, stroke, diabetic neuropathy, and spinal cord injury, produced by the same licensing organization. For Wharton's Jelly MSCs, the cell type is the same as used in thousands of published clinical studies, though specific batches vary by supplier.
Are stem cell treatments FDA-approved?
No stem cell therapy for the conditions Decima treats is currently FDA-approved. These are investigational treatments offered within applicable legal frameworks under physician supervision. We are transparent about this — it is why we require physician oversight for every case and why we maintain the documentation standards we do. If and when specific protocols receive FDA approval, we will say so explicitly.
Why does Decima not use fat-derived (adipose) stem cells?
Adipose-derived stem cells are one of the most commonly used cell types in US-based regenerative medicine clinics because they are easy to harvest from the patient's own fat. However, the evidence for their efficacy in systemic or orthopedic applications is significantly weaker than for Wharton's Jelly MSCs and MUSE cells. We focus on the cell types with the strongest evidence profile, which are both from allogeneic (donor) sources processed under GMP conditions.
What happens if I have an adverse reaction?
Your physician is on call throughout every treatment and for 48 hours after. We have a documented adverse event protocol. Patients receive a direct contact number for their physician, not a general support line. Adverse events from MSC and MUSE cell administration are rare — the most common reported effects are mild fatigue and localized soreness — but we treat every treatment session as the serious medical procedure it is.
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