Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-13

Study Completion Date

2022-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19

NCT04615429

Acute Respiratory Distress Syndrome COVID-19 Pneumonia

UNKNOWN PHASE2

Direct Topical Lung T3 Treatment to Improve Outcome & Sequelae of COVID-19 Acute Respiratory Distress Syndrome

NCT04725110

Covid19 SARS-CoV Infection ARDS +1 more

NOT_YET_RECRUITING PHASE2

Efficacy and Safety Evaluation of BZ371B in ARDS Patients

NCT05384379

ARDS ARDS, Human Pulmonary Disease

TERMINATED EARLY_PHASE1

Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS

NCT06505941

Acute Respiratory Distress Syndrome

NOT_YET_RECRUITING PHASE1/PHASE2

Cellular Immuno-Therapy for COVID-19 ARDS Randomized Clinical Trial

NCT04865107

Covid19 Acute Respiratory Distress Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.

The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.

Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 SARS-CoV 2 Adult Respiratory Distress Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

Wharton-Jelly mesenchymal stromal cells on D1 and D3

Group Type EXPERIMENTAL

XCEL-UMC-BETA

Intervention Type DRUG

Administration on top of the standard administered treatment

Treatment B

Placebo on D1 and D3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administration on top of the standard administered treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

XCEL-UMC-BETA

Administration on top of the standard administered treatment

Intervention Type DRUG

Placebo

Administration on top of the standard administered treatment

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WJ-MSC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Positive PCR fpr SARS-CoV-2
2. Intensive Care Unit admission for less than 3 days
3. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg)
4. Male or female, aged 18 to 70 years old
5. Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)

Exclusion Criteria

1. Expected survival less than 3 days
2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
3. Neoplastic disease either active or without complete remission
4. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
5. Pregnant or lactating women
6. Participation in another clinical trial with an experimental drug in the last 30 days
7. Other pathologies that, in medical judgment, contraindicate participation in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No