Study of Descartes-30 in Acute Respiratory Distress Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2023-09-09

Brief Summary

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Emergency study to test the safety of Descartes-30 cells in patients with moderate-to-severe acute respiratory distress syndrome (ARDS) AND COVID-19

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Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Descartes 30

Group Type EXPERIMENTAL

Descartes 30

Intervention Type BIOLOGICAL

Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.

Interventions

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Descartes 30

Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients must be 18 years of age or older at the time of enrollment
* Patient maintains a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS

Exclusion Criteria

* Patient is currently enrolled into another therapeutic clinical trial with an experimental therapy that has not received marketing approval by U.S. FDA.
* Patient is in moribund state with expected survival \<24 hours.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No