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

NCT04645485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-27

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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+.

Sponsors & Collaborators

  • Abu Dhabi Stem Cells Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-12
Primary Completion
2020-06-30
Completion
2020-07-30

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04645485 on ClinicalTrials.gov