Blood And Marrow TransplantationPhase 1NCT02804945
Mesenchymal Stem Cells (MSCs) for Treatment of Acute Respiratory Distress Syndrome (ARD) in Patients With Malignancies
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Blood And Marrow Transplantation and Adult Respiratory Distress Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood And Marrow Transplantation, Adult Respiratory Distress Syndrome
- What is being tested?
- Mesenchymal Stem Cells (MSCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 13 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients age >/=18 years.
- Treated with appropriate maximal medical therapy for pulmonary toxicity.
- Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patient or legally appropriate proxy must be able to understand study instructions and sign consent.
Who cannot join
- Unstable ventricular tachycardia or fibrillation.
- Moribund patients not expected to survive up to 48 hours.
- Patients with ARDS resulting from trauma.
- Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months.
- Patients with severe chronic liver disease (Childs-Pugh score > 10).
- Patients with previous solid organ transplant.
- Pregnant and/or lactating women.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies
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.
Read the detailed description
The MSCs:
MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs used in this study were collected from healthy donors and are stored and grown in a laboratory at MD Anderson. The product you will receive is from a healthy donor that is not related to you.
MSC Administration:
If you are found to be eligible to take part in this study, you will receive MSCs by vein over about 1-2 hours 1 time on Day 1.
Study Visits:
On Days 1 and 3:
- Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.
- Blood (about ½ teaspoon) will be drawn to check the oxygen level in your blood.
On Days 14 and 30:
°Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.
On Days 30 and 60:
°You will be checked for possible reactions to your treatment, including graft-versus-host disease (GVHD - a reaction of the donor's immune cells against your body). This will be checked by physical exam, by the doctor reviewing your side effects, and blood from standard of care blood draws.
Length of Study:
Your participation on this study will end after the Day 60 study visit. You will be taken off study early if you are not able to receive the MSC infusion(s), if intolerable side effects occur, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.
- Being tested
- Mesenchymal Stem Cells (MSCs)
- Keywords
- Blood And Marrow Transplantation, Adult Respiratory Distress Syndrome, ARDS, Allogeneic human mesenchymal stem cells, hMSCs, Placebo, Plasma-Lyte A solution, Standard of Care, Recent onset pulmonary toxicity
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cells (MSCs)Biological
Participants receive a maximum dose of 3 x 10^6 cell/Kg by vein one time on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells | Experimental | 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. Receives: Biological: Mesenchymal Stem Cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Adverse Events determined by CTCAE version 4.
Measured: 30 days
Secondary outcomes (2)
Clinical Improvement of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Clinical improvement defined as decreased mechanical ventilation after the mesenchymal stem cell (MSC) infusion.
Measured: Baseline, 7 days and 30 days
Improvement in PF or S/F Ratio of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
An improvement in PF or S/F ratio defined as decreased mechanical ventilatory requirement.
Measured: Baseline, 7 days and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start24 Feb 2017
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood And Marrow TransplantationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Katz Foundation
- Responsible party
- Sponsor
- Investigators
- Amanda L. Olson, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804945
- Sponsor's protocol ID
- 2015-0327
- Other IDs
- NCI-2016-01184
- Status last verified
- Apr 2020
- First submitted
- 15 Jun 2016
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome in Patients With Malignancies
- ClinicalTrials.gov ID
- NCT02804945
- Acronym / sponsor ID
- 2015-0327
- Keywords
- Blood And Marrow Transplantation, Adult Respiratory Distress Syndrome, ARDS, Allogeneic human mesenchymal stem cells, hMSCs, Placebo, Plasma-Lyte A solution, Standard of Care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Katz Foundation
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The MSCs:
MSCs are a type of stem cell that can be removed from bone marrow and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs used in this study were collected from healthy donors and are stored and grown in a laboratory at MD Anderson. The product you will receive is from a healthy donor that is not related to you.
MSC Administration:
If you are found to be eligible to take part in this study, you will receive MSCs by vein over about 1-2 hours 1 time on Day 1.
Study Visits:
On Days 1 and 3:
- Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.
- Blood (about ½ teaspoon) will be drawn to check the oxygen level in your blood.
On Days 14 and 30:
°Blood (about 2 tablespoons) will be drawn for routine tests, to check your heart, kidney, and liver function, and for biomarker testing.
On Days 30 and 60:
°You will be checked for possible reactions to your treatment, including graft-versus-host disease (GVHD - a reaction of the donor's immune cells against your body). This will be checked by physical exam, by the doctor reviewing your side effects, and blood from standard of care blood draws.
Length of Study:
Your participation on this study will end after the Day 60 study visit. You will be taken off study early if you are not able to receive the MSC infusion(s), if intolerable side effects occur, if the doctor thinks it is in your best interest, or if you are unable to follow study directions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cells | Experimental | Biological: Mesenchymal Stem Cells (MSCs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients age >/=18 years.
- Treated with appropriate maximal medical therapy for pulmonary toxicity.
- Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patient or legally appropriate proxy must be able to understand study instructions and sign consent.
Key exclusion criteria (7 listed)
- Unstable ventricular tachycardia or fibrillation.
- Moribund patients not expected to survive up to 48 hours.
- Patients with ARDS resulting from trauma.
- Patients with documented deep venous thrombosis or pulmonary embolism within the past 3 months.
- Patients with severe chronic liver disease (Childs-Pugh score > 10).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem Cells (MSCs)Participants receive a maximum dose of 3 x 10^6 cell/Kg by vein one time on Day 1. | Biological | Mesenchymal Stem Cells |
Primary outcome
Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Time frame: 30 days
Adverse Events determined by CTCAE version 4.
2 secondary outcomes
Clinical Improvement of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Time frame: Baseline, 7 days and 30 days
Improvement in PF or S/F Ratio of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD)
Time frame: Baseline, 7 days and 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda L. Olson, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stem Cells (MSCs) in people with Blood And Marrow Transplantation and Adult Respiratory Distress Syndrome, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of Participants Treated with Allogeneic Human Mesenchymal Stem Cells (hMSCs) With Acute Respiratory Distress Syndrome (ARD) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.