Clinical Study for Subjects With COVID-19 Using Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells

NCT05017298 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CTX0020-004
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.

Conditions

Corona Virus Infection; Covid19

Outcome Measures

Primary Outcomes (3)

• Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects.

  Incidence of treatment-related adverse events and severe adverse events during the study period

  6 months

• Safety for AdMSCs based upon incidence of all AEs

  Grouped by Medical Dictionary for Regulatory Activities (MedDRA)

  6 months

• Compare the mortality rate

  AdMSC treating group vs. control group

  6 months

Secondary Outcomes (9)

• Recognized immune measurements evaluating patients' symptom changes and overall function

  6 months

• Organ functional tests including blood specific enzymes and proteins

  6 months

• Duration (days) of weaning from mechanical ventilation

  6 months

• Duration (days) of ICU monitoring

  6 months

• Duration (days) of vasoactive agent's usage

  6 months

Other Outcomes (2)

• Mortality rate down to 0%

  6 months

• Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care.

Biological: Allogeneic adipose-derived stem cells

Control Group

PLACEBO COMPARATOR

The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care.

Biological: Allogeneic adipose-derived stem cells

Interventions

Allogeneic adipose-derived stem cells BIOLOGICAL

Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Also known as: Celltex-AdMSCs

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years.
• Male and female
• Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
• Diagnosed as COVID-19 based upon SARS-CoV-2 RT-PCR test positive
• Clinical diagnosis meets severe and/or critical parameters
• Male participants must be willing to ensure their partners do not become pregnant either by practicing abstinence or the use of condoms during sexual activity

You may not qualify if:

• Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
• Unwillingness or inability to comply with study procedures
• Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
• Clinically active malignant disease
• Subjects who are receiving ECMO and CRRT currently
• History of known pulmonary embolism or known secondary anti-phospholipid syndrome
• Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
• Known or suspected allergic to diphenhydramine.
• Major trauma or surgery within 14 days of study treatment start
• Mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study
• Alcohol, drug, or medication abuse within one year prior to study treatment start
• Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
• Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
• Patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
• History of long-term use of immunosuppressive agents

Sponsors & Collaborators

• Celltex Therapeutics Corporation: lead

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Derek W Guillory, MD

  Root Causes Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Young, Ph.D.

CONTACT

7135901000; jyoung@celltexbank.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 23, 2021
• Study Start: November 1, 2024
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 15, 2026
• Last Updated: February 7, 2024

Record last verified: 2023-04