Last reviewed · How we verify
NCT05490173
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
NA trial testing Exosomes derived from mesenchymal stromal cells (MSCs) in Premature Birth in 10 participants. Not yet recruiting.
22 May 2026
Quick facts
| Lead sponsor | Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 10 |
| Start date | 5 October 2022 |
| Primary completion | 22 May 2026 |
| Estimated completion | 28 December 2026 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Exosomes derived from mesenchymal stromal cells (MSCs)
Conditions studied
- Premature Birth — all drugs for Premature Birth →
- Extreme Prematurity — all drugs for Extreme Prematurity →
- Preterm Intraventricular Hemorrhage — all drugs for Preterm Intraventricular Hemorrhage →
- Hypoxia-Ischemia, Cerebral — all drugs for Hypoxia-Ischemia, Cerebral →
Sponsor
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Who can join
Adults 1 Day to 3 Days, any sex, with Premature Birth or Extreme Prematurity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Extracellular vesicles as tools and targets in therapy for diseases.
Kumar MA, Baba SK, Sadida HQ, Marzooqi SA, et al · · 2024 · cited 686× · PMID 38311623 · DOI 10.1038/s41392-024-01735-1 -
Clinical applications of stem cell-derived exosomes.
Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0 -
New strategies of neurodegenerative disease treatment with extracellular vesicles (EVs) derived from mesenchymal stem cells (MSCs).
Palanisamy CP, Pei J, Alugoju P, Anthikapalli NVA, et al · · 2023 · cited 86× · PMID 37554286 · DOI 10.7150/thno.83066 -
Extracellular vesicles arising from apoptosis: forms, functions, and applications.
Gregory CD, Rimmer MP. · · 2023 · cited 64× · PMID 37294158 · DOI 10.1002/path.6138 -
Extracellular Vesicles as Therapeutic Resources in the Clinical Environment.
Sanz-Ros J, Mas-Bargues C, Romero-García N, Huete-Acevedo J, et al · · 2023 · cited 53× · PMID 36768664 · DOI 10.3390/ijms24032344 -
Extracellular vesicles set the stage for brain plasticity and recovery by multimodal signalling.
Hermann DM, Peruzzotti-Jametti L, Giebel B, Pluchino S. · · 2024 · cited 45× · PMID 37768167 · DOI 10.1093/brain/awad332 -
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653 -
Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
Verify or expand the search:
- PubMed search for NCT05490173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Premature Birth
Currently open trials in the same condition.
- NCT07490912 — Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/o · recruiting
- NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
- NCT07306793 — The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body We · NA · recruiting
- NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
- NCT06340971 — Air Pollution and Pregnancy · recruiting
Other Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare trials
Trials by the same sponsor.
- NCT06641154 — Gene Therapy for Crigler Najjar Syndrome Type I (AlphaCN) · Phase 1, PHASE2 · recruiting
- NCT05678192 — Effect of Menopausal Hormone Therapy on Immune System Parameters · Phase 1 · completed
- NCT05455151 — Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05490173 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
- Last refreshed: 28 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05490173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing