Skip to content

A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscope on outcome of severe lung contusion

A comparison of two stem cells utilization methods; intravenous and intra alveolar injection by bronchoscopy on outcome of severe lung contusion in patients admitted to intensive care unit (ICU)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20101220005426N12
Enrollment
30
Registered
2022-10-29
Start date
2022-11-06
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung contusion. Contusion of lung

Interventions

Intervention 1: Intervention group 1: The first group will receive 60 million dental pulp stem cells intravenously in addition to common supportive treatments. Intervention 2: Intervention group 2: Th

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The pressure of arterial oxygen to inspiratory oxygen should be less than 180(PaO2/FIO2<180) Bilateral infiltration with pulmonary edema in anterior lung radiography Pulmonary contusion greater than 40% in chest CT scan The need to transfer to the intensive care unit due to respiratory failure Criteria 1-4 must all be present within a 24-hour period at the time of study entry

Exclusion criteria

Exclusion criteria: More than 96 hours have passed since the patient's ARDS trauma Pregnant or lactating woman Presence of any active malignancy (other than nonmelanoma skin cancer) that requires treatment within 2 years Any irreversible disease such as malignancies and a condition with a 50% chance of death within the next six months Moderate to severe liver disorder based on Child-Puff criteria<12 chronic obstructive pulmonary disease(COPD) The patient has undergone a lung transplant The patient's lack of consent, or if the patient is unable to answer, the patient's guardian's lack of consent A patient who is not expected to be alive in the next 24 hours according to the Apache criteria Class III or IV pulmonary hypertension Pulmonary embolism or deep vein thrombosis in the past three months Brain trauma Transfusion of large volume of blood (injection of more than 10 units of blood in the last 24 hours) The presence of heart failure, kidney and diabetes Patients in a state of shock and previous concurrent contusion

Design outcomes

Primary

MeasureTime frame
Arterial oxygen pressure to inspiratory oxygen pressure ratio. Timepoint: The ratio of arterial oxygen pressure to inspiratory oxygen pressure at the beginning of the study (before the start of the intervention) and 1, 4 and 10 days after cell injection in intervention and control groups. Method of measurement: ABG.;Average duration (days) of ventilation. Timepoint: After the intervention, daily until the end of hospitalization. Method of measurement: check list.;Death. Timepoint: death between 28 and 60 days after the start of the study. Method of measurement: Check list.;Average period of stay in ICU. Timepoint: The average period of stay in the ICU between 28 and 60 days after the start of the study in the intervention and control groups. Method of measurement: check list.;Need for intubation. Timepoint: Need for intubation during the study. Method of measurement: Check list.;Forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC). Timepoint: forced expiratory volume in the first one second to the forced vital capacity(FEV1/FVC) at the 1, 3 and 6 months after the start of study in intervention and control groups. Method of measurement: spirometry.;Forced vital capacity. Timepoint: Forced vital capacity at the 1, 3 and 6 months after the start of study in intervention and control groups. Method of measurement: spirometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Ahmadinejad

Kerman University of Medical Sciences

mehdia50@gmail.com+98 34 0223 5011

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026