PULMONARY FIBROSIS SECONDARY TO ARDS OR ALLOIMMUNE REACTION AFTER TRANSPLANTATION MedDRA version: 21.1 Level: LLT Classification code 10022619 Term: Interstitial pulmonary fibrosis System Organ Class: 100000004855
Conditions
Interventions
Product Name: cellule mesenchimali stromali allogeniche da midollo osseo
Product Code: [BM-MSC]
Pharmaceutical Form: Suspension for injection
Current Sponsor code: BM-MSC
Concentration unit: IU/kg int
Sponsors
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for cohort A: ¿ Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible. ¿ Male or female adults at time of enrolment age =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Exclusion criteria for cohort A ¿ Patients who received an investigational agent within 28 days before enrolment. ¿ In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. ¿ Stage 3 and 4 severe chronic kidney disease or requiring dialysis. ¿ Pregnancy ¿ Current documented and uncontrolled bacterial infection or septic shock. ¿ Imminent need of an ECMO or ECCO2R support ¿ Ongoing ECMO or ECCO2R support ¿ Late stage ARDS with CT scan indicating clear finding of advanced fibrosis in a major part of the lung tissues. Exclusion criteria for cohort B1 ¿ Patients who received an investigational agent within 28 days before enrolment. ¿ Any uncontrolled active systemic infection or active infection requiring systemic treatment that is ongoing = 7 days before enrolment. This does not include secondary prophylaxis of well controlled fungal infections, ongoing treatment of controlled viral reactivations (e.g., CMV), or treatment or prophylaxis of controlled low grade central line infections (e.g., Staphylococcus epidermidis). ¿ Any subject with a concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the subject. ¿ Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk. ¿ Female subject who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months of the last dose of study drug. Male subject who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug. Exclusion criteria for cohort B2 ¿ Patients who received an investigational agent within 28 days before enrolment. ¿ Any uncontrolled active systemic infection or active infection requiring systemic treatment that is ongoing = 7 days before enrolment. This does not include secondary prophylaxis of well controlled fungal infections, ongoing treatment of controlled viral reactivations (e.g., CMV), or treatment or prophylaxis of controlled low grade central line infections (e.g., Staphylococcus epidermidis). ¿ Progressive underlying malignant disease or active post-transplant lymphoproliferative disease. ¿ Any subject with a concurrent illness which in the opinion of the investigator may interfere with the treatment and evaluation of the subject. ¿ Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk. ¿ Female subject who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months of the last dose of study drug. Male subject who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of MSC treatment. For cohort A: any case of venous thromboembolism (VTE) or pulmonary embolism (PE), in the 48 hour period following MSC infusion. For cohort B: number of new onset infections and colonisations in the first 3 months after MSC therapy start.;Secondary Objective: Initial efficacy of MSC therapy. For cohort A: Key secondary endpoint: clinical improvement over a period of 1 month, defined as decrease in WHO scale score by 2 points on the ten-category ordinal scale or discharged alive from the hospital, whichever comes first For cohort B: Key secondary endpoint: Lung function stabilization, defined as = 15% decline of FEV1 over the 6 months post-treatment with respect to baseline values. In cohort B2, for patients not evaluable with lung function tests (i.e., young children), change in HR lung CT scan pattern, measured as differential % inflated areas pre- post-treatment, will be used.;Primary end point(s): Safety of MSC treatment. For cohort A: any case of venous thromboembolism (VTE) or pulmonary embolism (PE), in the 48 hour period following MSC infusion. For cohort B: number of new onset infections and colonisations in the first 3 months after MSC therapy start.;Timepoint(s) of evaluation of this end point: For cohort A: any case of venous thromboembolism (VTE) or pulmonary embolism (PE), in the 48 hour period following MSC infusion. For cohort B: number of new onset infections and colonisations in the first 3 months after MSC therapy start. | — |
Countries
Italy
Contacts
Public ContactSC AR II - CARDIOTORACICA
Fondazione IRCCS Policlinico San Matteo
Outcome results
None listed