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Septic ShockPhase 1AMETHYSTNCT04961658

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

A Phase 1 study testing GEM00220 in people with Septic Shock, run by Northern Therapeutics at 4 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock
What is being tested?
GEM00220
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
4 sitesCanada
Study dates
11 Aug 2021to 8 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients age 18 years and older
  • Receipt of appropriate antibiotics for the suspected/confirmed bacterial sepsis as the main diagnosis according to the opinion of the treating staff physician.
  • Hypotension documented within 48 hours prior to enrolment that requires the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, or dopamine >5 mcg/kg/min) for at least 3 hours within 24 hours prior to infusion, despite adequate fluid resuscitation in the opinion of the qualified investigator.
  • At least 1 other new organ dysfunction defined by the following:
  • Renal: Acute kidney injury with creatinine ≥ 150 µmol/L, or ≥ 1.5x the upper limit of normal or the known baseline creatinine, or < 0.5 ml/kg/hr urine output for 6 hours despite adequate fluid resuscitation or requirement for new renal replacement therapy (patients on chronic hemodialysis or peritoneal dialysis must meet one of the other organ dysfunction criteria)
  • Respiratory: Need for invasive mechanical ventilation or a P/F ratio < 250
  • Hematological: Platelets < 100 x10^9/L, or a drop of 50 x10^9/L in the 3 days prior to enrollment
  • Metabolic Acidosis: Arterial pH < 7.30 in association with base deficit > 5 mmol/L OR a lactate >/= to 3.0 mmol/L

Who cannot join

  • Pregnant or lactating
  • Currently receiving extracorporeal life support
  • Major surgery within this hospitalization and not prophylactically anticoagulated
  • Documented history of a hypercoagulable state (eg Factor V Leiden) or heparin-induced thrombocytopenia (HIT)
  • Body Mass Index (BMI) > 35
  • Documented COVID-19 (SARS-CoV2) within 30 days
Show all 19Show fewer
  • Documentation of viral lung infection as the primary diagnosis (e.g. influenza infection, respiratory syncytial virus (RSV) infection, or other laboratory-confirmed viral lung infection)
  • Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the past year
  • Documented history of severe heart failure with a New York Heart Association Functional Class of III or IV, or severe ischemic heart disease with a Canadian Cardiovascular Society angina class score of III or IV
  • Documented history of moderate to severe chronic liver disease (Childs-Pugh Score > 12)
  • Documented history of peripheral vascular disease with a Rutherford classification greater than Grade I, Category 2: moderate claudication
  • Severe chronic respiratory disease with a baseline PaCO2 > 50 mm Hg or the use of home oxygen
  • Documented deep venous thrombosis or pulmonary embolism
  • Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use >6months)
  • Documented, uncontrolled HIV infection or end stage HIV/AIDS with CD4+ T-cell counts <50 cells/mm^3, history of hepatitis B, untreated hepatitis C, or active tuberculosis
  • Concurrent use of immunomodulatory biologic drugs or TNF-α inhibitors
  • Participation in another interventional study involving an investigational new drug within 30 days prior to enrolment
  • Moribund patient not expected to survive 24 hours
  • Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Markham Stouffville Hospital - Oak Valley Health

    Markham, Ontario, L3P 7P3

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Read the detailed description

This trial consists of 2 sequential parts using the same trial infrastructure:

Phase 1a: A dose escalating and safety trial with pre-defined stopping rules for safety. Up to 12 participants will receive a single infusion of GEM00220. If no safety issues are identified, we will continue to the Phase 1b trial at the maximum feasible tolerated dose.

Phase 1b: A single-arm, open-label extension of the Phase 1a trial to assess early signs of efficacy (major morbidity and mortality). The Phase 1b trial will enroll up to 9 participants to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population.

Conditions
Septic Shock
Being tested
GEM00220
Keywords
Sepsis, Bacteria, Septic Shock, Mesenchymal Stromal Cells, Inflammation, Mesenchymal Stem Cells, Infection
Medical subject headings
Shock, Septic, Sepsis, Inflammation, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEM00220Biological

    Cryopreserved allogeneic, enhanced MSCs administered as a single intravenous infusion

Study groups in NCT04961658
Study groupRoleWhat they receive
Treatment Arm - Dose Cohort 1ExperimentalParticipants will receive a single dose of GEM00220 at 15 million cells
Receives: Biological: GEM00220
Treatment arm - Dose Cohort 2ExperimentalParticipants will receive a single dose of GEM00220 at 60 million cells
Receives: Biological: GEM00220
Treatment arm - Dose Cohort 3ExperimentalParticipants will receive a single dose of GEM00220 at 150 million cells
Receives: Biological: GEM00220
Treatment arm - Dose Cohort 4ExperimentalParticipants will receive two doses of GEM00220 at 150 million cells each, seperated by 24 hours
Receives: Biological: GEM00220

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety of GEM00220 will be assessed by monitoring adverse events

    Measured: Baseline to 28 days

  2. Maximum Feasible Tolerated Dose

    The highest dose which does not meet any of the pre-defined stopping criteria

    Measured: Baseline to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start11 Aug 2021
  3. Primary completion10 Aug 2023
  4. Study completion8 Jan 2024

Why it stopped: Funding Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
A dose-escalation study evaluating GEM00220 cell therapy in 4 cohorts with 3 subjects per cohort. Study will proceed from lower dose to next higher dose if no safety concerns are observed in each cohort. If no safety issues are identified, we will continue to the Phase 1b trial. Phase 1b: A single-arm, open-label extension of the Phase 1a trial to assess early signs of efficacy (major morbidity and mortality). The Phase 1b trial will enroll up to 9 participants.
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961658
Sponsor's protocol ID
CT-GEM-001
Acronym
AMETHYST
Status last verified
Apr 2024
First submitted
24 Jun 2021
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEM00220 in people with Septic Shock, run by Northern Therapeutics at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety of GEM00220 will be assessed by monitoring adverse events (time frame: Baseline to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04961658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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