Determination of safety of allogeneic mesenchymal stem cells by pilot method in patients with cystic fibrosis

Determination of the safety of using allogeneic mesenchymal stem cells by pilot method in patients with cystic fibrosis referred to the Children's Medical Center

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211110053033N1

Enrollment

Registered

2022-01-02

Start date

2021-12-26

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Cystic fibrosis. Cystic fibrosis

Interventions

Intervention 1: Intervention group: In 5 patients with cystic fibrosis in the peripheral vein, human allogeneic mesenchymal stem cells (Allo-hMSC ) will be injected in a single dose of 20 million cel

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of cystic fibrosis Severe obstructive disease defined as FEV1 / FVC less than 50% Acceptable function of other organs including creatinine level less than 1.5 times normal limit in each age group, ALT level less than 135, AST level less than 3 times normal limit in each age group, bilirubin level less than 1.5 times Normal limit in any age group Normal heart function on echocardiogram Patients in the age range of 12 to 18 years

Exclusion criteria

Exclusion criteria: The presence of any viral or bacterial infection that has caused pneumonia Patients with Heart Failure Patients with mental and physical disabilities

Design outcomes

Primary

Measure	Time frame
Lung Volume (Forced expiratory volume in one second);(FEV1). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Vital Capacity); (FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Expiratory flow 25_75%); (FEF25-75%). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Forced expiratory volume in 1 second to forced vitalcapacity (FEV1/FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Walking distance upon 6 minute walking distance test(meter). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Six minute walking distance test.;Body Mass Index. Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Weight (kilogram) divided by height squared (centimetre).	—

Measure

Time frame

Lung Volume (Forced expiratory volume in one second);(FEV1). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Vital Capacity); (FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Lung Volume (Forced Expiratory flow 25_75%); (FEF25-75%). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Forced expiratory volume in 1 second to forced vitalcapacity (FEV1/FVC). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Spirometry.;Walking distance upon 6 minute walking distance test(meter). Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Six minute walking distance test.;Body Mass Index. Timepoint: At the first visit and follow-up for up to a year. Method of measurement: Weight (kilogram) divided by height squared (centimetre).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Bolboli

Tehran University of Medical Sciences

faezeh.bolboli@gmail.com+98 21 6147 0011

Outcome results

None listed

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