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

NCT ID: NCT05017298

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-11-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

Allogeneic adipose-derived stem cells

Intervention Type: BIOLOGICAL

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

Control Group

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

Group Type: PLACEBO_COMPARATOR

Allogeneic adipose-derived stem cells

Intervention Type: BIOLOGICAL

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

Interventions

Allogeneic adipose-derived stem cells

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Celltex-AdMSCs

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Organ transplants in the past 6 months
• Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study.
• Patients with previous pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia before COVID-19 infection. The pulmonary imaging revealed the interstitial damage of lungs before the COVID-19 confirmed.
• QT interval shows greater than 450 ms in males and 470 ms in females in the medical histories or during screen EKG test.
• Subjects are not medically unstable at time of infusion including but not limiting unstable hypertension, pulse, oximetry, etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltex Therapeutics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek W Guillory, MD

Role: PRINCIPAL_INVESTIGATOR

Root Causes Medicine

Central Contacts

Jane Young, Ph.D.

Role: CONTACT

jyoung@celltexbank.com

7135901000

Other Identifiers

CTX0020-004

Identifier Type: -

Identifier Source: org_study_id