Acute Lung InjuryPhase 1/2NCT02175303
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
A Phase 1/2 study testing Decidual stromal cell therapy in people with Acute Lung Injury and Decidual Stromal Cells, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lung Injury, Decidual Stromal Cells, Stem Cell Transplantation
- What is being tested?
- Decidual stromal cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2013to Dec 2017
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with toxicity, inflammation or hemorrhages.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 14186
Olle Ringdén, MD, PhD, +46858582672, olle.ringden@ki.se
Olle Ringdén, MD, PhD
About this study
To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.
Read the detailed description
Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
- Being tested
- Decidual stromal cell therapy
- Medical subject headings
- Acute Lung Injury, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decidual stromal cell therapyBiological
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Decidual stromal cell therapy for toxicity and inflammation | Experimental | Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response. Receives: Biological: Decidual stromal cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Up to one year after inclusion
Secondary outcomes (9)
Anti-inflammatory and reparatory effects regarding different lesions.
Clinical, neurophysiological and radiological evaluation of the lesions in question.
Measured: Up to one year after inclusion
Time to disappearance of hemorrhages.
Measured: Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.
Measured: Up to one year after inclusion
Time to disappearance of pain.
Measured: Up to one year after inclusion
Time to disappearance of pulmonary infiltrates
Disappearance of inflammatory processes in the lung.
Measured: Up to one month after inclusion
Time to disappearance of oxygen supplementation
Measured: Up to one month after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral and fungal infections.
Measured: Up to one year after inclusion
Incidence of graft versus host disease
Measured: Up to one year after inclusion
Actuarial survival
Measured: Up to 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olle Ringdén, Karolinska Institutet
- Investigators
- Olle Ringdén, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175303
- Sponsor's protocol ID
- DSCINF001
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
- ClinicalTrials.gov ID
- NCT02175303
- Acronym / sponsor ID
- DSCINF001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Jun 2014 (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.
To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.
Detailed description
Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decidual stromal cell therapy for toxicity and inflammation | Experimental | Biological: Decidual stromal cell therapyPatients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with toxicity, inflammation or hemorrhages.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Decidual stromal cell therapyDecidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals. | Biological | Decidual stromal cell therapy for toxicity and inflammation |
Primary outcome
Number of adverse events
Time frame: Up to one year after inclusion
9 secondary outcomes
Anti-inflammatory and reparatory effects regarding different lesions.
Time frame: Up to one year after inclusion
Time to disappearance of hemorrhages.
Time frame: Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.
Time frame: Up to one year after inclusion
Time to disappearance of pain.
Time frame: Up to one year after inclusion
Time to disappearance of pulmonary infiltrates
Time frame: Up to one month after inclusion
Time to disappearance of oxygen supplementation
Time frame: Up to one month after inclusion
Incidence of severe infections
Time frame: Up to one year after inclusion
Incidence of graft versus host disease
Time frame: Up to one year after inclusion
Actuarial survival
Time frame: Up to 5 years after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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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.
Olle Ringdén, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Decidual stromal cell therapy in people with Acute Lung Injury and Decidual Stromal Cells, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2014. 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 Sweden. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olle Ringdén, MD, PhD (+46858582672, olle.ringden@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Up to one year after inclusion). 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 26 Jun 2014.