Safety and clinical effectiveness of autologous mesenchymal stromal cell infusion as adjunct treatment in patients with Idiopathic Pulmonary Fibrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008790

Enrollment

Registered

2015-07-13

Start date

2015-08-31

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J84.1

Interventions

Group 1: Single infusion of autologous MSC will be given to patients with IPF in addition to conventional therapy. Conventional therapy can include: non-pharmacological (oxygen, if hypoxic

pulmonary rehabilitation)

pharmacological (prescribed after specialists discussion in accordance with “An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Manageme

treatment of comorbidities (pulmonary hypertension and gastroesophageal reflux) and symptoms control. Group 2: Patients with IPF on conventional therapy. Conventional therapy can include: non-pharmaco

treatment of comorbidities (pulmonary hypertension and gastroesophageal reflux) and symptoms control.

Eligibility

Sex/Gender

All

Age

21 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients 21 through 75 years of age with diagnose of IPF based on diagnostic criteria of “An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management”. The duration of the disease should be more than three months, bilateral predominantly basilar inspiratory crackles should be present. In addition, the following functional abnormalities should be present: dyspnea, vital capacity of no more than 80 percent of the predicted value, single-breath carbon monoxide diffusing capacity (DLCO) less than 80 percent of the predicted value.

Exclusion criteria

Exclusion criteria: Any one of the criteria below makes the patient non-eligible for enrolment into the study: 1. HIV positivity 2. Hepatitis B or C positivity 3. Tuberculosis 4. Autoimmune or systemic diseases 5. Pregnancy 6. liver, renal or other organ/system failure(s) 7. Sepsis 8. Cancer 9. Younger than 21 years and older than 75 years

Design outcomes

Primary

Measure	Time frame
The primary end points are the following: the adverse events, the changes in vital capacity and DLCO between baseline and month 6, 12.	—

Secondary

Measure	Time frame
Chest X-ray and CT scan at baseline, 6 and 12 months, and mortality during 12 months	—

Countries

Belarus

Contacts

Public ContactAlena Skrahina

The Rupublican Research and Practical Centre for Pulmonology and TB

alena_skrahina@tut.by+375 17 2898356

Outcome results

None listed

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