HealthyPhase 1SANTANANCT04645485
Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers.
A Phase 1 study testing Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). in people with Healthy, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 May 2020to 30 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Abu Dhabi Stem Cells Center
Abu Dhabi, 4600
About this study
Official title: 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).
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).
Read the 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
- Being tested
- Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).
- Keywords
- Nebulization, Autologous non-hematopoietic peripheral blood stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).Biological
Also called UAECell19
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+.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). Receives: Biological: Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 0-28.
St. George's Respiratory Questionnaire (SGRQ) scoring.
Assessment of scoring changes.
Measured: Days 0, 28.
Nebulization tolerability rate.
Proportion of participants that tolerate the NHPBSC nebulization successfully.
Measured: Days 0, 1.
Adverse Events (AEs) tolerability rate.
Proportion of participants that tolerate AEs -if any, and finish the study.
Measured: Days 0-28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start12 May 2020
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Stem Cells Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645485
- Sponsor's protocol ID
- CT.002.1.0.SANTANA
- Acronym
- SANTANA
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT04645485
- Acronym / sponsor ID
- SANTANA / CT.002.1.0.SANTANA
- Conditions
- Healthy
- Keywords
- Nebulization, Autologous non-hematopoietic peripheral blood stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Abu Dhabi Stem Cells CenterOther government
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Biological: Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).Also: UAECell19Participants 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+. | Biological | Experimental arm |
Primary outcome
Adverse reactions (AR) incidence.
Time frame: Days 0-28.
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.
St. George's Respiratory Questionnaire (SGRQ) scoring.
Time frame: Days 0, 28.
Assessment of scoring changes.
Nebulization tolerability rate.
Time frame: Days 0, 1.
Proportion of participants that tolerate the NHPBSC nebulization successfully.
Adverse Events (AEs) tolerability rate.
Time frame: Days 0-28.
Proportion of participants that tolerate AEs -if any, and finish the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC). in people with Healthy, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions (AR) incidence. (time frame: Days 0-28.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.