Premature BirthNCT05490173
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
A study testing Exosomes derived from mesenchymal stromal cells (MSCs) in people with Premature Birth and Extreme Prematurity, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
Trial summary
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage
- What is being tested?
- Exosomes derived from mesenchymal stromal cells (MSCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 5 Oct 2022to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature newborns of gestational age (GA) 25/0-27/6 weeks,
Who cannot join
- Missing written parental consent
- Damages to the nasal mucosa
- Maxillofacial defects
- Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)
- Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
- Infants with edematous hemolytic disease of newborns, non-immune fetal dropsy,
- Multifetal Gestations
- Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Moscow, 117997
Elena A Gorodnova, PhD, +7 (495) 531-44-44, e_gorodnova@oparina4.ru
Diiana Sharafutdinova, +79859865567, dikarush@gmail.com
About this study
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.
Read the detailed description
Surviving extremely low birth weight (ELBW) infants are at risk of severe neurodevelopmental disability. Exosomes or extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) can mediate a variety of different effects, including synaptic plasticity, nutritional metabolic support, nerve regeneration, inflammatory response, anti-stress effect, cellular waste disposal, treating neurological injury, preventing hemorrhagic and ischemic brain lesions, playing an important role in health and neuroprotection in extremely premature newborns during neonatal intensive care.
The proposed blinded randomized controlled trial was designed to compare the effect of intranasal administration of exosomes on long-term neurodevelopmental outcome in ELBW infants.
ELBW infants will be randomized to receive (group 1) and not receive exosomes (control group).
Group 1 - Neonates will receive exosomes (1 dose will be obtained from a daily conditioned culture medium of 120 million MSCs) suspended in 500 µl of phosphate buffer in each nostril at 50 µl with an interval of 2-3 minutes. The therapeutic course will consist of 5 instillations with an interval of 1 days.
The primary outcome measure is the incidence of death, the incidence of survival with any of either severe intraventricular hemorrhage (IVH), cystic periventricular leukomalacia (PVL), or brain injury on cranial ultrasound and MRI or major neurodevelopmental impairment determined at 36 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Cognitive delay defined as mental developmental index (MDI) score of the Griffiths-II and Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment.
To investigate this outcomes and the mechanisms by which extracellular vesicles (EVs) might effect we will analyze the biomarkers of perinatal brain injury (S-100, NSE, EPO) and mRNA.
Key secondary outcomes are incidences of short term outcomes: individual components of the composite primary outcome, survival with and without major neonatal morbidity including severe retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC).
Safety analyses will assess the injures or damages of the nasal mucosa, allergic reaction to EVs and any adverse events after intranasal administration of EVs.
The results of this trial may help to improve the quality of life of ELBW infants and reduce long-term health care costs.
- Conditions
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage, Hypoxia-Ischemia, Cerebral, Neurodevelopmental Disorders
- Being tested
- Exosomes derived from mesenchymal stromal cells (MSCs)
- Keywords
- Extremely low birth weight, neuroprotection
- Medical subject headings
- Premature Birth, Hypoxia-Ischemia, Brain, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosomes derived from mesenchymal stromal cells (MSCs)Other
Exosomes derived from mesenchymal stromal cells (MSCs) will be administered intranasal in ELBW infants
| Study group | Role | What they receive |
|---|---|---|
| Intranasal exosomes administration | Experimental | ELWB newborns who will receive intranasal exosomes Receives: Other: Exosomes derived from mesenchymal stromal cells (MSCs) |
| Control | No intervention | ELWB newborns who will not receive intranasal exosomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and rate of dose limiting toxicity
Dose limiting toxicity consists of the following events:
Death occurring within 24 hours after intranasal administration of EVs; Hypersensitivity / anaphylactic to EVs defined as any severe systemic inflammatory response syndrome with negative blood culture not consistent with the overall clinical course of the infant occurring within 72 hours after intranasal administration of EVs; Any other serious adverse event not expected in this patient population for which there is no alternative explanation but the administration of EVs, occurring within 1 week of injection.
Measured: Up to 1 week following after intranasal administration of EVs
Secondary outcomes (10)
Rate of death
Rate of death until discharge or 40 weeks corrected gestational age, whichever comes first
Measured: From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
Occurrence of Other Severe Complications of Prematurity
- Blood culture-proven sepsis
- Patent ductus arteriosus (treated medically or surgically)
- Necrotizing enterocolitis
- Isolated intestinal perforation
- Retinopathy of prematurity requiring treatment
- Severe intraventricular hemorrhage (≥ grade 3)
- Cystic periventricular leukomalacia
- Incidence and Severity of BPD, Measured as mild, moderate, or severe
Measured: From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
Need for Ventilatory Support
- Time to extubation
- Duration of mechanical ventilation
- Duration of non-invasive positive pressure respiratory support
- Duration of supplemental oxygen
Measured: From enrollment until discharge, 40 weeks corrected gestational age, or death (whichever occurs first)
Changes in Hemodynamics
Targeted neonatal echocardiography to assess
Measured: Time Frame: At enrollment, 48 hours following intranasal administration of EVs, 28 days of life, and 36 weeks corrected gestational age
Feasibility: Administration
Successful recruitment and administration of extracellular vesicles to 10 patients in 18 months
Measured: Day of life 1-10
Feasibility: Recruitment Efficiency
- Proportion of potentially eligible patients that are successfully screened
- Proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded)
Measured: Day of life 1-10
Feasibility: Recruitment Timing
- Median time from screening to enrollment
- Median time from screening to extracellular vesicles
Measured: Day of life 1-10
Feasibility: Participant Retainment
- Proportion of patients that do not complete administration of extracellular vesicles
- Proportion of patients enrolled that do not undergo scheduled follow-up
Measured: From enrollment until follow-up at 18-36 months-of-age
Griffiths-II and Bayley Scales of Infant Development (2nd edition)
Assessment of cognitive, language, and motor development. Cognitive delay defined as mental developmental index (MDI) score of the Griffiths-II and Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment.
Measured: 18-36 months-of-age
Long-term Safety Follow-Up
Participant's overall health will be assessed through a questionnaire administered over the phone, once a year for 3 years
Measured: 3 years following follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start5 Oct 2022 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants (ELBW infants GA 25/0-27/6 week) are randomized to one of two groups in parallel for the duration of the study. The first group (exosome treatment group) will receive intranasal administration of exosomes and the second (control group) will not receive exosomes. Patients in both groups will receive standard basic therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oleg Ionov, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOVEkaterina Balashova, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOVDenis Silachev, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOVAnna Kirtbaya, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOVVictor Zubkov, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOVDmitriy Degtyarev, PhD, MD, Principal investigator, NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490173
- Sponsor's protocol ID
- ncagp4382277
- Status last verified
- Sep 2022
- First submitted
- 4 Jul 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ophelders DR, Wolfs TG, Jellema RK, Zwanenburg A, Andriessen P, Delhaas T, Ludwig AK, Radtke S, Peters V, Janssen L, Giebel B, Kramer BW. Mesenchymal Stromal Cell-Derived Extracellular Vesicles Protect the Fetal Brain After Hypoxia-Ischemia. Stem Cells Transl Med. 2016 Jun;5(6):754-63. doi: 10.5966/sctm.2015-0197. Epub 2016 May 9.
PubMed 27160705Drommelschmidt K, Serdar M, Bendix I, Herz J, Bertling F, Prager S, Keller M, Ludwig AK, Duhan V, Radtke S, de Miroschedji K, Horn PA, van de Looij Y, Giebel B, Felderhoff-Muser U. Mesenchymal stem cell-derived extracellular vesicles ameliorate inflammation-induced preterm brain injury. Brain Behav Immun. 2017 Feb;60:220-232. doi: 10.1016/j.bbi.2016.11.011. Epub 2016 Nov 12.
PubMed 27847282Gamage TKJB, Fraser M. The Role of Extracellular Vesicles in the Developing Brain: Current Perspective and Promising Source of Biomarkers and Therapy for Perinatal Brain Injury. Front Neurosci. 2021 Sep 24;15:744840. doi: 10.3389/fnins.2021.744840. eCollection 2021.
PubMed 34630028
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT05490173
- Acronym / sponsor ID
- ncagp4382277
- Conditions
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage, Hypoxia-Ischemia, Cerebral, Neurodevelopmental Disorders
- Keywords
- Extremely low birth weight, neuroprotection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of HealthcareOther government
- Study start
- 5 Oct 2022 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 5 Aug 2022 (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.
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.
Detailed description
Surviving extremely low birth weight (ELBW) infants are at risk of severe neurodevelopmental disability. Exosomes or extracellular vesicles (EVs) derived from mesenchymal stromal cells (MSCs) can mediate a variety of different effects, including synaptic plasticity, nutritional metabolic support, nerve regeneration, inflammatory response, anti-stress effect, cellular waste disposal, treating neurological injury, preventing hemorrhagic and ischemic brain lesions, playing an important role in health and neuroprotection in extremely premature newborns during neonatal intensive care.
The proposed blinded randomized controlled trial was designed to compare the effect of intranasal administration of exosomes on long-term neurodevelopmental outcome in ELBW infants.
ELBW infants will be randomized to receive (group 1) and not receive exosomes (control group).
Group 1 - Neonates will receive exosomes (1 dose will be obtained from a daily conditioned culture medium of 120 million MSCs) suspended in 500 µl of phosphate buffer in each nostril at 50 µl with an interval of 2-3 minutes. The therapeutic course will consist of 5 instillations with an interval of 1 days.
The primary outcome measure is the incidence of death, the incidence of survival with any of either severe intraventricular hemorrhage (IVH), cystic periventricular leukomalacia (PVL), or brain injury on cranial ultrasound and MRI or major neurodevelopmental impairment determined at 36 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Cognitive delay defined as mental developmental index (MDI) score of the Griffiths-II and Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment.
To investigate this outcomes and the mechanisms by which extracellular vesicles (EVs) might effect we will analyze the biomarkers of perinatal brain injury (S-100, NSE, EPO) and mRNA.
Key secondary outcomes are incidences of short term outcomes: individual components of the composite primary outcome, survival with and without major neonatal morbidity including severe retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC).
Safety analyses will assess the injures or damages of the nasal mucosa, allergic reaction to EVs and any adverse events after intranasal administration of EVs.
The results of this trial may help to improve the quality of life of ELBW infants and reduce long-term health care costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants (ELBW infants GA 25/0-27/6 week) are randomized to one of two groups in parallel for the duration of the study. The first group (exosome treatment group) will receive intranasal administration of exosomes and the second (control group) will not receive exosomes. Patients in both groups will receive standard basic therapy
| Arm | Type | Receives |
|---|---|---|
| Intranasal exosomes administration | Experimental | Other: Exosomes derived from mesenchymal stromal cells (MSCs)ELWB newborns who will receive intranasal exosomes |
| Control | No intervention | –ELWB newborns who will not receive intranasal exosomes |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature newborns of gestational age (GA) 25/0-27/6 weeks,
Key exclusion criteria (8 listed)
- Missing written parental consent
- Damages to the nasal mucosa
- Maxillofacial defects
- Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period)
- Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
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 |
|---|---|---|
| Exosomes derived from mesenchymal stromal cells (MSCs)Exosomes derived from mesenchymal stromal cells (MSCs) will be administered intranasal in ELBW infants | Other | Intranasal exosomes administration |
Primary outcome
Occurrence and rate of dose limiting toxicity
Time frame: Up to 1 week following after intranasal administration of EVs
Dose limiting toxicity consists of the following events: Death occurring within 24 hours after intranasal administration of EVs; Hypersensitivity / anaphylactic to EVs defined as any severe systemic inflammatory response syndrome with negative blood culture not consistent with the overall clinical course of the infant occurring within 72 hours after intranasal administration of EVs; Any other serious adverse event not expected in this patient population for which there is no alternative explanation but the administration of EVs, occurring within 1 week of injection.
10 secondary outcomes
Rate of death
Time frame: From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
Occurrence of Other Severe Complications of Prematurity
Time frame: From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)
Need for Ventilatory Support
Time frame: From enrollment until discharge, 40 weeks corrected gestational age, or death (whichever occurs first)
Changes in Hemodynamics
Time frame: Time Frame: At enrollment, 48 hours following intranasal administration of EVs, 28 days of life, and 36 weeks corrected gestational age
Feasibility: Administration
Time frame: Day of life 1-10
Feasibility: Recruitment Efficiency
Time frame: Day of life 1-10
Feasibility: Recruitment Timing
Time frame: Day of life 1-10
Feasibility: Participant Retainment
Time frame: From enrollment until follow-up at 18-36 months-of-age
Griffiths-II and Bayley Scales of Infant Development (2nd edition)
Time frame: 18-36 months-of-age
Long-term Safety Follow-Up
Time frame: 3 years following follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 27160705Ophelders DR, Wolfs TG, Jellema RK, Zwanenburg A, Andriessen P, Delhaas T, Ludwig AK, Radtke S, Peters V, Janssen L, Giebel B, Kramer BW. Mesenchymal Stromal Cell-Derived Extracellular Vesicles Protect the Fetal Brain After Hypoxia-Ischemia. Stem Cells Transl Med. 2016 Jun;5(6):754-63. doi: 10.5966/sctm.2015-0197. Epub 2016 May 9.
- Background: PubMed 27847282Drommelschmidt K, Serdar M, Bendix I, Herz J, Bertling F, Prager S, Keller M, Ludwig AK, Duhan V, Radtke S, de Miroschedji K, Horn PA, van de Looij Y, Giebel B, Felderhoff-Muser U. Mesenchymal stem cell-derived extracellular vesicles ameliorate inflammation-induced preterm brain injury. Brain Behav Immun. 2017 Feb;60:220-232. doi: 10.1016/j.bbi.2016.11.011. Epub 2016 Nov 12.
- Results publication: PubMed 34630028Gamage TKJB, Fraser M. The Role of Extracellular Vesicles in the Developing Brain: Current Perspective and Promising Source of Biomarkers and Therapy for Perinatal Brain Injury. Front Neurosci. 2021 Sep 24;15:744840. doi: 10.3389/fnins.2021.744840. eCollection 2021.
- The Role of Extracellular Vesicles in the Developing Brain: Current Perspective and Promising Source of Biomarkers and Therapy for Perinatal Brain InjuryLink provided by the sponsor.
- The Role of Extracellular Vesicles in the Developing Brain: Current Perspective and Promising Source of Biomarkers and Therapy for Perinatal Brain InjuryLink provided by the sponsor.
- Mesenchymal Stromal Cell-Derived Extracellular Vesicles Protect the Fetal Brain After Hypoxia-IschemiaLink provided by the sponsor.
- Mesenchymal stem cell-derived extracellular vesicles ameliorate inflammation-induced preterm brain injuryLink provided by the sponsor.
- 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.
Oleg Ionov, PhD, MD principal investigator
NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV
Ekaterina Balashova, PhD, MD principal investigator
NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV
Denis Silachev, PhD, MD principal investigator
NATIONAL MEDICAL RESEARCH CENTER FOR OBSTETRICS, GYNECOLOGYAND PERINATOLOGY NAMED AFTER ACADEMICIAN V.I.KULAKOV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exosomes derived from mesenchymal stromal cells (MSCs) in people with Premature Birth and Extreme Prematurity, run by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare at 1 site in Russia.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Sep 2022. 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 Russia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg Ionov, PhD, MD (+74954382277, dr.ionov@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and rate of dose limiting toxicity (time frame: Up to 1 week following after intranasal administration of EVs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05490173, which also lists 3 linked publications.
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 28 Sep 2022.