Stem Cell Transplant ComplicationsPhase 1NCT03187431
Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
A Phase 1 study testing autologous bone marrow mesenchymal stem cells in people with Stem Cell Transplant Complications, run by Assiut University.
Trial summary
Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- autologous bone marrow mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2017to 1 Dec 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years (both inclusive)
- high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia.
- Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses.
- The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present.
- dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum).
- FVC > 50% of the predicted normal value and DLco > 35% of the predicted value.
- Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment.
Who cannot join
- FVC < 50% predicted normal value and DLCO < 35%predicted normal value.
- lung cancer or with an evidence of active malignancyfor at least 5 years.
- uncontrolled heart failure.
- renal failure
- hepatic failure,
- neurological abnormalities including stroke and myasthenia Gravis
- Anti-coagulants therapy.
- Active infections.
About this study
Official title: Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells
- Conditions
- Stem Cell Transplant Complications
- Being tested
- autologous bone marrow mesenchymal stem cells
- Keywords
- Stem cell, Therapy, IPF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow mesenchymal stem cellsBiological
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| IPF patients | Experimental | autologous bone marrow mesenchymal stem cells Receives: Biological: autologous bone marrow mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
safety and side effects
Measured: 6 months
Secondary outcomes (2)
Post therapy diffusing capacity of CO% (DLCO)predicted
Efficacy of procedure
Measured: 6-12 months
post therapy forced vital capacity (FVC)% predicted.
efficacy of the procedure
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start11 Dec 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187431
- Sponsor's protocol ID
- AssiutU4
- Status last verified
- Jun 2017
- First submitted
- 11 Apr 2017
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03187431
- Acronym / sponsor ID
- AssiutU4
- Conditions
- Stem Cell Transplant Complications
- Keywords
- Stem cell, Therapy, IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 15 Jun 2017 (actual)
- 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.
Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF patients | Experimental | Biological: autologous bone marrow mesenchymal stem cellsautologous bone marrow mesenchymal stem cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years (both inclusive)
- high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia.
- Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses.
- The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present.
- dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum).
Key exclusion criteria (8 listed)
- FVC < 50% predicted normal value and DLCO < 35%predicted normal value.
- lung cancer or with an evidence of active malignancyfor at least 5 years.
- uncontrolled heart failure.
- renal failure
- hepatic failure,
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 |
|---|---|---|
| autologous bone marrow mesenchymal stem cellsintravenous infusion | Biological | IPF patients |
Primary outcome
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
Time frame: 6 months
safety and side effects
2 secondary outcomes
Post therapy diffusing capacity of CO% (DLCO)predicted
Time frame: 6-12 months
post therapy forced vital capacity (FVC)% predicted.
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous bone marrow mesenchymal stem cells in people with Stem Cell Transplant Complications, run by Assiut University.
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 7 inclusion and 8 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation (time frame: 6 months). 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 15 Jun 2017.