Safety Issues Clinical Trial
Official title:
Safety of Autologous Cord Blood Cells for Preterm Infants.
To assess the safety of autologous volume- and red blood cell (RBC)-reduced non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Preterm birth complications are one of the leading causes of death among children under 5
years of age. Despite advances in medical care, many survivors face a lifetime of disability,
including mental and physical retardation, and chronic lung disease. More recently, both
allogenic and autogenic cord blood cells have been applied in the treatment of neonatal
conditions such as hypoxic-ischemic encephalopathy (HIE) and bronchopulmonary dysplasia
(BPD).
Objective—To assess the safety of autologous volume- and red blood cell (RBC)-reduced
non-cryopreserved umbilical cord blood (UCB) cell infusion to preterm infants.
Method— This study was a phase I, open-label, single-arm, single center trial to evaluate the
safety of autologous, volume- and RBC-reduced non-cyropreserved UCB cell (5×107cells/kg)
infusion for preterm infants <37 weeks gestational age. UCB cell characteristics, pre- and
post- infusion vital signs, laboratory investigations were recorded. Clinical data including
mortality rates and preterm complications were recorded.
Results—After processing, (22.67±4.05) ml UCB cells in volume, (2.67±2.00)×108 cells in
number, with (22.67±4.05)×106 CD34+, and (3.72±3.25)×105colony forming cells (CFU-GM),
(99.7±0.17%) vitality were infused to 15 preterm infants within 8 hours after birth. No
adverse effects were noticed during treatment. All fifteen patients who received UCB infusion
survived. The duration of hospitalization ranged from 4 to 65 (30±23.6) days. Regarding
preterm complications, no BPD, necrotizing enterocolitis (NEC), retinopathy of prematurity
(ROP) were observed. There were 1/15 (7%) infant with intraventricular hemorrhage (IVH), and
5/15 (33.3%) infants with ventilation-associated pneumonia, 10/15(66.67%) with anemia
respectively.
Conclusions—Collection, preparation and infusion of fresh autologous UCB cells to preterm
infants is feasible and safe. Adequately powered randomized controlled studies are needed.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04485481 -
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT03473236 -
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
|
Phase 1 | |
Not yet recruiting |
NCT03683953 -
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
|
Phase 1 | |
Recruiting |
NCT05546567 -
NOPARK Open Label Extension Study
|
N/A | |
Recruiting |
NCT05413226 -
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
|
N/A | |
Recruiting |
NCT05112159 -
Study of IPG1094 in Healthy Participants
|
Phase 1 | |
Completed |
NCT04689035 -
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
|
Phase 1 | |
Completed |
NCT04335045 -
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
|
Phase 1 | |
Completed |
NCT05037227 -
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
|
||
Recruiting |
NCT05517291 -
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
|
N/A | |
Enrolling by invitation |
NCT06446778 -
Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
|
||
Recruiting |
NCT04573049 -
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
|
Phase 4 | |
Completed |
NCT05585463 -
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
|
||
Completed |
NCT04188821 -
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
|
N/A | |
Completed |
NCT03667430 -
Safety Evaluation of Porous Silica in Men
|
N/A | |
Completed |
NCT04499482 -
Safety and Tolerability of Soy Fiber
|
N/A | |
Completed |
NCT03141905 -
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
|
N/A | |
Completed |
NCT05244161 -
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
|
N/A | |
Recruiting |
NCT03791372 -
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
|
Phase 1 | |
Withdrawn |
NCT04759066 -
The HEALiX™ Intubated Patient (IP) Pilot Study
|
N/A |