CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

Lisata Therapeutics

Status and phase: Withdrawn; Phase 1

Conditions: Covid-19

Treatments: Biological: CLBS119

Study type: Interventional

Funder types: Industry

Identifiers

NCT04522817

CLBS119-P01

Details and patient eligibility

About

This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.

Full description

This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
• Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
• Evidence for ongoing pulmonary involvement based on P/F ratio <300
• Able to provide informed consent

Exclusion criteria

• Immunocompromised or current use of immunosuppressive agents other than corticosteroids
• History of autoimmune disease
• Evidence of multiorgan failure
• Subject is pregnant or lactating at the time of signing the consent
• Participation in any other clinical trial of an experimental treatment for COVID-19
• History of sickle cell disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

CLBS119 Active Treatment

Experimental group

Description:

Single administration of CLBS119

Treatment:

Biological: CLBS119