Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

Covid19 Clinical Trial

Official title:

A Phase 2a Study of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells to Treat Post COVID-19 "Long Haul" Pulmonary Compromise

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04909892
• Other study ID #: MSC-PLH-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2021
• Est. completion date: January 2022

Study information

• Verified date: September 2021
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1b study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise.

Description:

This is a Phase 1b multicenter study to assess the safety and efficacy of COVI-MSC in treating post COVID-19 "long haulers" with pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has had prior laboratory-confirmed SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
• Has had a recent (within a week) negative SARS-CoV-2 test (an approved PCR or antigen test)
• Has had at least moderate or severe post-COVID-19 pulmonary symptoms for at least 3 months which have resulted in reduced physical functioning compared to pre-COVID-19 status
• Willing to follow contraception guidelines

Exclusion Criteria:

• Clinically improving pulmonary status over the month prior to screening
• Undergone a previous stem cell infusion unrelated to this trial
• Pregnant or breast feeding or planning for either during the study
• Suspected uncontrolled active bacterial, fungal, viral, or other infection
• History of a splenectomy, lung transplant or lung lobectomy
• Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• COVI-MSC
COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-Minute Walk Distance (6MWD) at Day 60	Change in 6MWD at Day 60	Baseline to Day 60
Secondary	Change in 6MWD at Day 30	Change in 6MWD at Day 30	Baseline to Day 30
Secondary	Change in Pulmonary Function Tests (PFTs)	Change in PFTs at Days 30 and 60, as assessed using Forced Vital Capacity, Forced Expiratory Volume, Total Lung Capacity, and diffusing capacity for carbon monoxide (DLCO)	Baseline to Day 30 and Day 60
Secondary	Change in oxygenation	Change in oxygenation at Days 30 and 60, as measured using SpO2/FiO2 ratio	Baseline to Day 30 and Day 60
Secondary	Change in biomarker levels	Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor	Baseline through Day 30