Safety and efficacy of Mesenchymal Stem Cell administration in Bronchiolitis Obliterans Syndrome.

Evaluation of safety and efficacy of allogeneic adipose-derived mesenchymal stem cell administration in Bronchiolitis Obliterans Syndrome (BOS) after allogeneic hematopoietic stem cell transplantation.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201202049568N2

Enrollment

Registered

2021-02-22

Start date

2020-12-21

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

bronchiolitis obliterans. Respiratory bronchiolitis interstitial lung disease

Interventions

Intervention group: mesenchymal stem cells from the donors' adipose tissue will be extracted and then cultured in the laboratory. Final products will be injected with a dosage of 1 million per kg intr

Eligibility

Sex/Gender

All

Age

1 Months to 16 Years

Inclusion criteria

Inclusion criteria: Age below 16 years Allogeneic hematopoietic stem cell transplantation (HSCT) over the past year Forced Expiratory Volume in one second (FEV1) < 70 % (based on Pulmonary Function Test) Diagnosis of BOS in end-stage phase with the history and clinical evaluation by a pediatric pulmonologist, and the presence of air-trapping or small airway involvement in high-resolution computed tomography (HRCT) Absence of concomitant infections Irresponsible to full-dose corticosteroids Give the informed consent by the patients' legal guardians

Exclusion criteria

Exclusion criteria: Suspicion to any bacterial or viral pneumonia CMV, VZV, HSV and/or fungal pneumonia Haploidentical and/or T-cell deplete transplantation Prior history of allergy or sensitivity to drugs Relapse or progression of underlying malignancy

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume in one second (FEV1). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).;FEV1/FVC ratio. Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: Pulmonary Function Test (Spirometry).	—

Secondary

Measure	Time frame
Fractional exhaled nitric oxide (FeNO). Timepoint: Before intervention and then 1,3,6 months after intervention. Method of measurement: FeNO test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRashin Mohseni

Tehran University of Medical Sciences

rashin_mohseni@yahoo.com+98 21 6694 8444

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026