Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19

• Status: Completed
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

Summary

SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abu Dhabi Stem Cells Center

Criteria

Inclusion Criteria:

• RT-PCR Laboratory confirmation of COVID-19.

• Male or female aged ≥ 18 years.

• Interstitial lung change ≥ 3 judged by "Lungs Lobar based scoring" according to computed tomography (CT) scans.

• Hospitalized and symptomatic patients, referring one or more of the following symptoms (fever, cough, or shortness of breath), in association with (at least one): tiredness, runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or smell).

• Ability to comply with test requirements and peripheral blood stem cells collection.

• The patient or legal representative agrees to participate in the study, and signs the SENTAD-COVID Study informed consent form.

Exclusion Criteria:

• Pediatric patients (aged < 18 years).

• Diagnosis of any kind of shock.

• Organ transplants in the past 3 months.

• Patients receiving immunosuppressive therapy.

• Diagnostic of Hepatitis B Virus (HBV) infection.

• Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS).

• Current diagnosis of cancer.

• History of malignancies in the past 5 years.

• Pregnant or lactating women.

• Have participated in other clinical trials in the past 3 months.

• Inability to comply with test requirements and peripheral blood stem cells collection.

• Inability to provide informed consent.