NCT04961658 (AMETHYST) is a Phase 1 clinical trial of GEM00220 in Septic Shock, sponsored by Northern Therapeutics.

Who is sponsoring NCT04961658?

NCT04961658 is sponsored by Northern Therapeutics.

What drugs are being tested in NCT04961658?

Interventions in NCT04961658: GEM00220.

What condition does NCT04961658 study?

NCT04961658 studies Septic Shock.

Is NCT04961658 still recruiting?

NCT04961658 is currently terminated. Last updated 16 April 2024.

Last reviewed 2024-04-16 · How we verify

NCT04961658: AMETHYST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

Terminated Phase 1 Last updated 16 April 2024

What this trial tests

Phase 1 trial testing GEM00220 in Septic Shock in 11 participants. Terminated before completion.

Timeline

11 August 2021

Primary endpoint
10 August 2023

8 January 2024

Quick facts

Lead sponsor	Northern Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	11 August 2021
Primary completion	10 August 2023
Estimated completion	8 January 2024
Sites	4 locations across Canada

Drugs / interventions tested

GEM00220 — full drug profile →

Conditions studied

Septic Shock — all drugs for Septic Shock →

Sponsor

Northern Therapeutics — full company profile →

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of the Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting the host response in sepsis: current approaches and future evidence.
Bode C, Weis S, Sauer A, Wendel-Garcia P, et al · · 2023 · cited 56× · PMID 38057824 · DOI 10.1186/s13054-023-04762-6
Treatment Advances in Sepsis and Septic Shock: Modulating Pro- and Anti-Inflammatory Mechanisms.
Marques A, Torre C, Pinto R, Sepodes B, et al · · 2023 · cited 42× · PMID 37109229 · DOI 10.3390/jcm12082892
The MSC-EV-microRNAome: A Perspective on Therapeutic Mechanisms of Action in Sepsis and ARDS.
Dos Santos CC, Lopes-Pacheco M, English K, Rolandsson Enes S, et al · · 2024 · cited 38× · PMID 38247814 · DOI 10.3390/cells13020122
Therapeutic potential of mesenchymal stromal/stem cells in critical-care patients with systemic inflammatory response syndrome.
Martí-Chillón GJ, Muntión S, Preciado S, Osugui L, et al · · 2023 · cited 14× · PMID 36588089 · DOI 10.1002/ctm2.1163
Exosome-Derived microRNA: Potential Target for Diagnosis and Treatment of Sepsis.
Xiao Y, Yuan Y, Hu D, Wang H. · · 2024 · cited 12× · PMID 39104595 · DOI 10.1155/2024/4481452
Immunotherapy in the context of sepsis-induced immunological dysregulation.
Wu Y, Wang L, Li Y, Cao Y, et al · · 2024 · cited 11× · PMID 38835773 · DOI 10.3389/fimmu.2024.1391395
Stem cell therapies in the clinic.
Acharya S, Shaha S, Bibbey MG, Mukherji M, et al · · 2025 · cited 3× · PMID 40385529 · DOI 10.1002/btm2.70000
Mesenchymal stem/stromal cells as a therapeutic for sepsis: a review on where do we stand?
Premer C, Hare JM, Yuan SY, Wilson JW. · · 2025 · cited 3× · PMID 40375314 · DOI 10.1186/s13287-025-04371-w

Verify or expand the search:

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
NCT07383103 — Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock · Phase 4 · recruiting
NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting

Other Northern Therapeutics trials

Trials by the same sponsor.

NCT03001414 — Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension · Phase 2, PHASE3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04961658 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northern Therapeutics
Last refreshed: 16 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04961658.

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