Last reviewed 2026-06-03 · How we verify

ATCell

American CryoStem Corporation · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 0/100

ATCell is a Biologic drug developed by American CryoStem Corporation. It is currently in Phase 1 development. Also known as: Autologous Adipose Derived Mesenchymal Stem Cells.

ATCell is a treatment that involves the intravenous infusion of autologous, adipose-derived mesenchymal stem cells. It is being studied for the treatment of Post-Concussion Syndrome and Long COVID, with various dosages of 50, 150, and 300 adipose-derived stem cells being tested.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	ATCell
Also known as	Autologous Adipose Derived Mesenchymal Stem Cells
Sponsor	American CryoStem Corporation
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

ATCell CI brief — competitive landscape report
ATCell updates RSS · CI watch RSS
American CryoStem Corporation portfolio CI

Frequently asked questions about ATCell

What is ATCell?

ATCell is a Biologic drug developed by American CryoStem Corporation.

Who makes ATCell?

ATCell is developed by American CryoStem Corporation (see full American CryoStem Corporation pipeline at /company/american-cryostem-corporation).

Is ATCell also known as anything else?

ATCell is also known as Autologous Adipose Derived Mesenchymal Stem Cells.

What development phase is ATCell in?

ATCell is in Phase 1.

Manufacturer: American CryoStem Corporation — full pipeline
Also known as: Autologous Adipose Derived Mesenchymal Stem Cells

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing