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

NCT04645485 | Completed Phase 1

• 1 other identifier: CT.002.1.0.SANTANA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nebulization; Autologous non-hematopoietic peripheral blood stem cells

Outcome Measures

Primary Outcomes (4)

• Adverse reactions (AR) incidence.

  Proportion of participants with treatment-related adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and the WHO-UMC system for the causality assessment.

  Days 0-28.

• St. George's Respiratory Questionnaire (SGRQ) scoring.

  Assessment of scoring changes.

  Days 0, 28.

• Nebulization tolerability rate.

  Proportion of participants that tolerate the NHPBSC nebulization successfully.

  Days 0, 1.

• Adverse Events (AEs) tolerability rate.

  Proportion of participants that tolerate AEs -if any, and finish the study.

  Days 0-28.

Study Arms (1)

Experimental arm

EXPERIMENTAL

Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).

Biological: Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).

Interventions

Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). BIOLOGICAL

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+.

Also known as: UAECell19

Experimental arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female volunteers (18-50 years inclusive). Healthy subjects: volunteers not having any mental or physical diagnosed disorder or requiring regular or frequent medication, who is not known to suffer any significant illness, who should be within the ordinary range of body measurements)
• Non-smoking volunteers, based on self-reporting who have not used tobacco or nicotine-containing products (or less than 100 cigarettes or equivalent in his / her lifetime), including commercially available cigarettes, hand-rolled cigarettes, bidis, cigars, chewing tobacco, pipes, hookahs, shishas, snuff, snus, electronic cigarettes and similar devices, and nicotine replacement therapy within the last 12 months.
• Body mass index (BMI) ≥ 19 kg/m².
• For females: premenopausal, non-lactating, and non-pregnant.
• Ability to comply with test requirements and peripheral blood stem cell collection.
• The subject agrees to participate in the study and signs the SANTANA Study informed consent form.

You may not qualify if:

• Pediatric subjects (aged \< 18 years) or older than 50 years' volunteers.
• Any clinically relevant gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, and cardiovascular diseases or any other condition including clinically significant abnormal Laboratory parameters that, in the opinion of the Investigator, could jeopardize the safety of the subject.
• Current smoking subjects (or former smokers who have quit smoking three months before eligibility assessment).
• Body mass index (BMI) \< 19 kg/m².
• For females: Postmenopausal, lactating or pregnant women.
• Donation or receipt of whole blood or blood products within three months before the screening visit.
• Inability to comply with test requirements or peripheral blood stem cell collection.
• Organ or cell transplants in the past three months.
• History of malignancies in the past five years.
• Have participated in other clinical trials in the past three months.
• Employee of Abu Dhabi Stem Cells Center (ADSCC) or their first-degree relatives (parent, sibling, or child).
• Inability to provide informed consent.

Sponsors & Collaborators

• Abu Dhabi Stem Cells Center: lead

Study Sites (1)

Abu Dhabi Stem Cells Center

Abu Dhabi, 4600, United Arab Emirates

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2020
• First Posted: November 27, 2020
• Study Start: May 12, 2020
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)