Project goal: Develop a therapeutic strategy and evaluate the efficacy of mesenchymal stem cells to slow the progression of pulmonary fibrosis, preserve lung function and improve the quality of life of patients.
Type of study: multicenter, open.
Research design: randomised controlled clinical trial.
The study will include four groups of patients suffering from advanced interstitial pulmonary fibrosis:
1) The main group will consist of patients with ILD/ SCTD with a pattern of progressive fibrosis receiving nintedanib + mesenchymal cell therapy
2) The control group will consist of patients with ILD/ SCTD with a pattern of progressive fibrosis receiving nintedanib.
Patients in the study groups:
1. Age 18 – 70 years (inclusive)
2. Body weight ≥45 kg and <100 kg
3. Willingness and ability of the patient to read, understand, sign and date the study-approved informed consent form
4. Willingness and ability of the patient to comply with the protocol requirements and instructions, which include using the nebuliser at home and completing all required procedures and patient visits until the end of the study
5. Progressive pulmonary fibrosis:
• Detected on chest computed tomography (CT) scan,
• Increased respiratory symptoms, decreased exercise tolerance, and impaired quality of life (Modified Dyspnoea Scale score ≥1 and <3, SpO2 <90%.
• Decreased lung function: FVC, OFV1 or DLCO expected <90% and expected FVC ≥50%, respectively
• Receiving treatment with Nintedanib at a dose of 150 to 300mg/day orally in a stable dose for at least 4 weeks prior to the study
Exclusion criteria:
1. Evidence of poorly controlled concomitant clinically significant diseases: cardiovascular system, nervous system, lung, liver, kidney, endocrine system, haematological, metabolic, gastrointestinal, neurological, oncological and infection specific diseases requiring primary main treatment.
2. History of confirmed or positive result on screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
3. Pregnant women or nursing (breastfeeding) mothers.
4. Any medical or psychological condition that, in the opinion of the Principal Investigator, may interfere with the safe completion of the study.
Expected results: This project will examine the efficacy of MSC in treating PPF, leveraging their antifibrotic properties. The goal is to develop and standardize approaches for the clinical application of MSC, tailored to the specific nature of each disease.
For the first time in the Republic of Kazakhstan, the optimal methods for MSC administration, including dosage and speed of delivery, will be studied to create modern, safe treatment methods that address challenges in rheumatology and pulmonology. Special attention will be paid to the potential use of MSC in combination with medication therapy to more effectively slow the fibrotic process in the lungs.
The effectiveness of MSC therapy will be evaluated through laboratory diagnostics in patients with progressive interstitial lung fibrosis. The implementation of this project will mark the first application of cellular therapy in Kazakhstan’s clinical practice for the comprehensive treatment of PPF in interstitial lung diseases and systemic sclerosis, leading to significant improvements in patient quality of life, and reductions in mortality and disability.
Project Manager: Baigenzhin Abai, Chairman of the Management Board of JSC "National Scientific Medical Center", Doctor of Medical Sciences. He is the President of the Association of Pulmonologists of Central Asia, Executive Director of the Euro-Asian Respiratory Society, full member of the European Academy of Natural Sciences, member of the Presidium of the World Health Organization Committee.
Со-Project Manager: Alexey Mikhailovich Pak, PhD, Director of the Institute of Internal Medicine, NNMC JSC
Project executors (members of the temporary research team):
Nimenko S.A. – Candidate of Medical Sciences, pulmonologist
Zarkumova Zh.Z. – researcher, pulmonologist
Kayyrly N.M. – researcher, pulmonologist
Zaripova L.N. – PhD, rheumatologist
Zhakupova A.H. – biotechnologist specialist
Rakhimzhanova A.K. – biotechnologist specialist
Payzullayeva S.N. – MBA, Scientific Manager
Kozina L.V. – Candidate of Medical Sciences, laboratory physician
Zhunusov A.J. – surgeon
Ergalieva A.S. – bacteriologist specialist
Smailov M.B. – anesthesiologist
Tasbaeva I.A. – operating nurse
Mendybayeva E.M. – economist
Bakirova S.A. – doctoral student
Study period: 2025-2027
Financing: grant financing of the Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
Project publications: major publications are planned for 2026-2027