Clinical trial · Interventional
Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies
A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn about the safety of giving mesenchymal stem cells (MSCs) to patients who have ARDS. Researchers also want to learn if these cells can help control ARDS when given with drugs that are routinely used to treat ARDS. In this study, participants will receive 1 infusion of MSCs. This is an investigational study. MSC infusions for the treatment of ARDS is investigational. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Respiratory Distress Syndrome | — | UNRESOLVED | — |
| Blood And Marrow Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesenchymal Stem Cells (MSCs) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mesenchymal Stem Cells
- description
- Participants receive Mesenchymal Stem Cells (MSCs) for adult respiratory distress syndrome (ARDS). Participants receive a maximum dose of 3 x 10\^6 cell/Kg by vein one time on Day 1.
- interventionNames
- Biological: Mesenchymal Stem Cells (MSCs)
Primary outcomes (1)
- measure
- Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
- timeFrame
- 30 days
- description
- Adverse Events determined by CTCAE version 4.
Secondary outcomes (2)
- measure
- Clinical Improvement of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ARDS characterized by hypoxemia and bilateral radiographic opacities not fully explained by cardiac failure or fluid overload as judged by the treating physician using all available data. Moderate ARDS includes patients with malignancies with the previous presentation and a P/F ratio \</= 200 or SF ratio of \</= 214. The duration of the hypoxemia criterion and the radiograph criterion must be within 10 days of the time of enrollment. 2. Patients age \>/=18 years. 3. Treated with appropriate maximal medical therapy for pulmonary toxicity. 4. Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 5. Patient or legally appropriate proxy must be able to understand study instructions and sign consent. Exclusion Criteria: 1. Unstable ventricular tachycardia or fibrillation. 2. Moribund patients not expected to survive up to 48 hours. 3. Patients with ARDS resulting from trauma. 4. Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months. 5. Patients with severe chronic liver disease (Childs-Pugh score \> 10). 6. Patients with previous solid organ transplant. 7. Pregnant and/or lactating women.
References
Publications (0)
Data not yet available