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

Celltex Therapeutics

Status and phase: Not yet enrolling; Phase 2

Conditions: Corona Virus Infection; Covid19

Treatments: Biological: Allogeneic adipose-derived stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT05017298

CTX0020-004

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

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.

Treatment:

Biological: Allogeneic adipose-derived stem cells

Control Group

Placebo Comparator group

Description:

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

Treatment:

Biological: Allogeneic adipose-derived stem cells