Table 2 Clinical trials in MCS therapy on pulmonary fibrosis
From: Application of Wharton jelly-derived mesenchymal stem cells in patients with pulmonary fibrosis
NO | Title and sponsor | Trial ID | Source of MSC | location | Design | Primary outcome | Recruitment status | Phase |
|---|---|---|---|---|---|---|---|---|
1. | Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF Sponsor: The Foundation for Orthopaedics and Regenerative Medicine | NCT05016817 | UC-MSC | Island in Antigua and Barbuda | Open Label, Interventional, Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Idiopathic Pulmonary Fibrosis N:20 | Safety (adverse events) | Recruiting August 23, 2021 | Phase 1 |
2. | Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER) (AETHER) Sponsor: Joshua M Hare | NCT02013700 | – | United States, Florida | A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary Fibrosis N: 9 | To determine the safety and tolerability of intravenous allo hMSCs in patients with Idiopathic Pulmonary Fibrosis (IPF) | Terminated (Study completed) March 9, 2021 | Phase 1 |
3. | Infusion of Allogeneic Mesenchymal Stem Cells in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement Sponsor: Universidad de la Sabana | NCT04432545 | WJ-MSC | Colombia | Expanded Access, Infusion of Allogeneic Stromal Mesenchymal Stem Cells From Wharton´s Jelly in Patients With Diffuse Cutaneous Systemic Sclerosis With Refractory Pulmonary Involvement to Treatment | – | Available June 16, 2020 | – |
4. | A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells Sponsor: Jianwu Dai | NCT02277145 | UC-MSC | China, Chongqing | Interventional, open-label, Phase I Study of Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells N:10 | Composite indicators, including quantitative analysis of CT density histograms, self-evaluation and changes of TGF-β1 content Safety Evaluation | Completed July 24, 2019 | Phase 1 |
5. | Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia | NCT02594839 | BM-MSC | Moscow, Russian Federation | Open Label, Randomized, A Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease N:20 | Safety: Number of serious adverse events | Completed January 9, 2018 | Phase 1 Phase 2 |
6. | Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis (CMM/FPI) Sponsor: Clinica Universidad de Navarra, Universidad de Navarra | NCT01919827 | BM-MSC | Salamanca, Spain | Open Label, Interventional, Treatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem Cells N:17 | Number of participants with adverse side effects | Completed May 3, 2018 | Phase 1 |
7. | Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis Sponsor: Assiut University | NCT03187431 | BM-MSC | Egypt | Open Label, Interventional, Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis N:12 | Number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation | Unknown June 15, 2017 | Phase 1 |
8. | A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis (MSC in IPF) Sponsor: The Prince Charles Hospital | NCT01385644 | PD-MSC | Minnesota, United States | Open Label, Single Group Assignment, A Phase I Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis N:8 | Number of Participants Who Demonstrated Acute Adverse Events Following Infusion | Completed December 29, 2015 | Phase 1 |
9. | Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary Fibrosis Sponsor: Kasiak Research Pvt. Ltd | NCT02135380 | AD-MSC | India | A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intravenous Autologous Adipose Derived Adult Stem Cells for Treatment of Idiopathic Pulmonary Fibrosis (IPF) N:210 | Safety | Unknown May 13, 2014 | Phase 1 Phase 2 |