NCT04645485

Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers.

A Phase 1 Study Evaluating the Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers in Abu Dhabi, 2020 (SANTANA Study).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Abu Dhabi Stem Cells Center · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

SANTANA Study is a phase 1, prospective, monocentric, open-label clinical trial involving healthy adult volunteers, with the objective to evaluate the safety and tolerability of the compressor nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).

Detailed description

The study was conducted in Abu Dhabi Stem Cells Center (ADSCC), and the cell processing and investigational product formulation were performed at the same center according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). Participants received the investigational therapy through compressor (jet) nebulization (two doses divided on Days 0 and 1). The primary endpoint was the safety assessment, to be measured as Adverse Reactions (ARs) incidence \[by the World Health Organization - Uppsala Monitoring Centre (WHO-UMC) causality assessment system\], and the nebulization tolerability rate (Days 0 and 1). The Laboratory testing profile was evaluated before treatment (Day 0 or -1) and on Days 14 and 28. Two thorax radiography tests (chest X-rays - CXR) were assessed: before the therapy (Day 0 or -1) and on Day 7. An electrocardiogram (ECG) assessment was performed on Days 0 (or -1), 14, and 28. The application of the validated St. George's Respiratory Questionnaire (SGRQ) on Days 0 and 28 was a surrogate safety endpoint. The whole clinical assessment in SANTANA Study was daily recorded until Day 28, taking into account the ARs incidence. The secondary endpoint was the tolerability assessment, measured by nebulization tolerability rate (Days 0 and 1), and Adverse Events (AEs) tolerability within 28-days. The trial was approved by the ADSCC Research Ethics Committee, and written informed consent was obtained from all participants. SANTANA Study was conducted following the Declaration of Helsinki principles and Good Clinical Practices (GCPs), and the authors are responsible for designing the trial, compiling, and analyzing the data.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).	Participants received the investigational therapy through compressor (jet) nebulization, in two doses divided on Days 0 and 1. Each dose contains 10 mL of peripheral blood-derived stem cells CD45-/CD90+/CD133+.

Timeline

• Start date: 2020-05-12
• Primary completion: 2020-06-30
• Completion: 2020-07-30
• First posted: 2020-11-27
• Last updated: 2020-11-27

Locations

1 site across 1 country: United Arab Emirates