Method for treating inflammatory lung diseases using mesenchymal lineage precursor or stem cells
The present disclosure relates to method of treating or preventing an inflammatory lung disease in a subject in need thereof, the method comprising administering to the subject a composition comprising mesenchymal lineage precursor or stem cells (MLPSCs).
1 . A method of treating an inflammatory lung disease in a human subject in need thereof, the method comprising administering to the subject a composition comprising a population of culture expanded mesenchymal lineage precursor or stem cells (MLPSCs), wherein the subject has a circulating C-reactive protein (CRP) level of ≥2 mg/L, wherein the inflammatory lung disease is selected from the group consisting of Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Arterial Hypertension (PAH), and asthma, and wherein the subject has an improvement in one or more of the following after treatment:
Forced expiratory volume in one second (FEV1);
Forced vital capacity (FVC);
FEV1/FVC and;
6 minute walk test.
2 . The method of claim 1 , wherein the MLPSCs are culture expanded from an intermediate cryopreserved MLPSCs population.
3 . The method of claim 1 , wherein the composition is administered intravenously.
4 . The method of claim 1 , wherein the MLPSCs are mesenchymal stem cells (MSCs).
5 . The method of claim 1 , which comprises administering between 1×10 7 and 2×10 8 cells per dose, wherein a dose is administered at baseline followed by 3 subsequent monthly doses over 90 days.
6 . The method of claim 1 , which comprises administering about 1×10 8 cells per dose, wherein a dose is administered at baseline followed by 3 subsequent monthly doses over 90 days.
7 . The method of claim 1 , wherein the subject has an FEV1 change from baseline of at least 0.02, within 120 days of treatment.
8 . The method of claim 1 , wherein the subject has an FEV1 change from baseline of at least 0.05, within 120 days of treatment.
9 . The method of claim 1 , wherein the subject has an FVC change from baseline of at least 0.05, within 120 days of treatment.
10 . The method of claim 1 , wherein the subject has an FVC change from baseline of at least 0.1, within 120 days of treatment.
11 . The method of claim 1 , wherein the subject has an FEV1/FVC change from baseline of at least 0.01, within 120 days of treatment.
12 . The method of claim 1 , wherein the subject has an FEV1/FVC change from baseline of at least 0.015, within 120 days of treatment.
13 . The method of claim 1 , wherein the subject shows an improvement in the 6 minute walk test of at least 40 meters, within 60 days or within 120 days of treatment.
14 . The method of claim 1 , wherein the subject shows an improvement in the 6 minute walk test of at least 50 meters, within 60 days or within 120 days of treatment.
15 . The method of claim 1 , wherein the composition comprises greater than 6.68×10 6 viable cells/mL.