Search
Close this search box.

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

Studies

Study First Submitted Date 2021-07-28
Study First Posted Date 2021-08-05
Last Update Posted Date 2023-04-12
Start Month Year February 2024
Primary Completion Month Year July 2024
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-12

Detailed Descriptions

Sequence: 20688482
Description This is a Phase 2a randomized, placebo-controlled multicenter study designed to investigate the efficacy, safety and tolerability of COVI-MSC in treating post COVID-19 "long haul" pulmonary compromise. COVI-MSC will be administered intravenously on Day 0, Day 2, and Day 4.

Conditions

Sequence: 52082700
Name Covid19
Downcase Name covid19

Id Information

Sequence: 40088142
Id Source org_study_id
Id Value MSC-PLH-201BR

Design Groups

Sequence: 55496619 Sequence: 55496620
Group Type Experimental Group Type Placebo Comparator
Title COVI-MSC Title Placebo
Description Allogeneic culture-expanded adipose-derived mesenchymal stem cells (MSCs) Description Excipient

Interventions

Sequence: 52395851 Sequence: 52395852
Intervention Type Biological Intervention Type Biological
Name COVI-MSC Name Placebo
Description 2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group. Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4 Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4 Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2 Group D: 2 MSC vials infused on D0, D2 and D4 Description 6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.

Keywords

Sequence: 79722677 Sequence: 79722678 Sequence: 79722679
Name covid19 Name long haul Name post-acute covid
Downcase Name covid19 Downcase Name long haul Downcase Name post-acute covid

Design Outcomes

Sequence: 177077791 Sequence: 177077792 Sequence: 177077793 Sequence: 177077794 Sequence: 177077795 Sequence: 177077796
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in 6-Minute Walk Distance (6MWD) at Day 60 Measure Change in 6MWD at Day 30 Measure Relief of symptoms on Day 30 and Day 60 Measure Change in Pulmonary Function Measure Change in oxygenation Measure Change in biomarker levels
Time Frame Baseline to Day 60 Time Frame Baseline to Day 30 Time Frame Baseline to Day 30 and Day 60 Time Frame Baseline to Day 30 and Day 60 Time Frame Baseline to Day 30 and Day 60 Time Frame Baseline to Day 60
Description Change in 6MWD at Day 60 Description Change in 6MWD at Day 30 Description Relief of symptoms on Day 30 and Day 60 based on a categorical Symptom Relief Scale, where 0 = no benefit and 4 = nearly complete benefit Description Change in pulmonary function at Days 30 and 60, as measured by the single-breath test Description Change in oxygenation at Days 30 and 60, as measured by the SpO2/FiO2 ratio Description Change in biomarker levels: plasma lipocalcin-2, matrix metalloproteinase-7, hepatocyte growth factor

Browse Conditions

Sequence: 193135006 Sequence: 193135007 Sequence: 193135008 Sequence: 193135009 Sequence: 193135010 Sequence: 193135011 Sequence: 193135012 Sequence: 193135013 Sequence: 193135014 Sequence: 193135015 Sequence: 193135016 Sequence: 193135017
Mesh Term COVID-19 Mesh Term Pneumonia, Viral Mesh Term Pneumonia Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Virus Diseases Mesh Term Coronavirus Infections Mesh Term Coronaviridae Infections Mesh Term Nidovirales Infections Mesh Term RNA Virus Infections Mesh Term Lung Diseases Mesh Term Respiratory Tract Diseases
Downcase Mesh Term covid-19 Downcase Mesh Term pneumonia, viral Downcase Mesh Term pneumonia Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term virus diseases Downcase Mesh Term coronavirus infections Downcase Mesh Term coronaviridae infections Downcase Mesh Term nidovirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term lung diseases Downcase Mesh Term respiratory tract diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48237361
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Sorrento Therapeutics, Inc.

Overall Officials

Sequence: 29233688
Role Study Director
Name Mike Royal, MD
Affiliation Sorrento Therapeutics, Inc.

Central Contacts

Sequence: 11990391
Contact Type primary
Name Mike Royal, MD
Phone (858)203-4100
Email mroyal@sorrentotherapeutics.com
Phone Extension 4146
Role Contact

Design Group Interventions

Sequence: 68031718 Sequence: 68031719
Design Group Id 55496619 Design Group Id 55496620
Intervention Id 52395851 Intervention Id 52395852

Eligibilities

Sequence: 30714028
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria 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 Any significant medical condition, laboratory value or other illness that in the investigator's opinion would interfere or prevent safe participation in the study History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253945680
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30460597
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28827056
Responsible Party Type Sponsor