Postoperative Air Leaks in Risk PatientsPhase 1/2CSM/FAP/2012NCT02045745
Clinical Trial Phase I/II Prospective, Open Nonrandomized for Treatmen of Postoperative Air Leak After Lung Resection in High Risk Patients Through the Administration of Mesenchymal Autologous Cells
A Phase 1/2 study testing Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line in people with Postoperative Air Leaks in Risk Patients, run by Red de Terapia Celular at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Air Leaks in Risk Patients
- What is being tested?
- Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years
- Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)
- Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria.
Who cannot join
- Patients with any of the following exclusion criteria may not be included in the clinical trial:
- Those considered by the investigator are not on a good position to tolerate the procedure
- Clinical criteria and anesthetics that contraindicate surgery
- Uncontrolled severe disease
- Pregnant women
- Patients infected with hepatitis B, hepatitis C, syphilis and HIV + virus
- People who are taking a drug under clinical investigation or participated in any study under clinical investigation (or an authorized product) within 30 days prior to randomization
- The absence of informed consent or revocation thereof
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Clinical Hospital of Salamanca
Salamanca, Salamanca/Castilla León, 37007
Fermín Sánchez-Guijo Martín, Ph.D, +34923294624, ferminsg@usal.es
Marcelo F Jiménez López, Ph.D
About this study
Official title: CLINICAL TRIAL PHASE I / II, PROSPECTIVE, OPEN, NONRANDOMIZED, FOR TREATMENT OF POSTOPERATIVE AIR LEAK AFTER LUNG RESECTION IN HIGH RISK PATIENTS THROUGH THE ADMINISTRATION OF MESENCHYMAL AUTOLOGOUS CELLS.
The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.
- Conditions
- Postoperative Air Leaks in Risk Patients
- Being tested
- Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line
- Keywords
- Postoperative air leaks in risk patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture lineBiological
Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro
| Study group | Role | What they receive |
|---|---|---|
| Prolonged postoperative air leaks in risk patients. | Experimental | Patients with prolonged postoperative air leaks Receives: Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure
Security is measured in terms of: Adverse effects derived from the implantation of the CSM
Measured: During the procedure and postoperative period (48 hours)
Secondary outcomes (1)
Analyze the efficacy of the procedure
Clinical:
- Duration of postoperative air leak
- Amount of leakage and trends measured by digital memory device
- Cardiorespiratory complications
Radiological:
- Pneumothorax on chest radiograph.
Measured: Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Air Leaks in Risk PatientsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Red de Terapia Celular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Castilla y León Hematology and hemotherapy Foundation, Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
- Responsible party
- Sponsor
- Investigators
- Marcelo F Jiménez López, Ph.D, Principal investigator, University Clinical Hospital of SalamancaGonzalo Varela Simó, Ph.D, Study chair, University Clinical Hospital of SalamancaNuria M Novoa Valentín, Ph.D, Study chair, University Clinical Hospital of SalamancaJosé L Aranda Alcaide, Ph.D, Study chair, University Clinical Hospital of SalamancaConsuelo del Cañizo, Ph.D, Study director, University Clinical Hospital of SalamancaFermín Sánchez-Guijo Martín, Ph.D, Study chair, University Clinical Hospital of SalamancaOlga López Villar, Ph.D, Study chair, University Clinical Hospital of SalamancaEva M Villarón Ríos, Ph.D, Study chair, University Clinical Hospital of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045745
- Sponsor's protocol ID
- CSM/FAP/2012
- Other IDs
- 2013-000535-27
- Acronym
- CSM/FAP/2012
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2014
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jimenez MF, Gomez-Hernandez MT, Villaron EM, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded with Tissucol Duo(R) for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2023 Oct 31;14(1):313. doi: 10.1186/s13287-023-03545-8.
PubMed 37904229
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL TRIAL PHASE I / II, PROSPECTIVE, OPEN, NONRANDOMIZED, FOR TREATMENT OF POSTOPERATIVE AIR LEAK AFTER LUNG RESECTION IN HIGH RISK PATIENTS THROUGH THE ADMINISTRATION OF MESENCHYMAL AUTOLOGOUS CELLS.
- ClinicalTrials.gov ID
- NCT02045745
- Acronym / sponsor ID
- CSM/FAP/2012 / CSM/FAP/2012
- Conditions
- Postoperative Air Leaks in Risk Patients
- Keywords
- Postoperative air leaks in risk patients.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Red de Terapia CelularIndustry (pharma, biotech, devices)
- Collaborators
- Castilla y León Hematology and hemotherapy Foundation, Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jan 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.
The purpose of this study is to analyze the safety and feasibility of the implantation of autologous mesenchymal stem cells (MSCs) expanded "in vitro" and administered directly in the lung line of suture as a treatment for patients at risk of postoperative air leaks after lung resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged postoperative air leaks in risk patients. | Experimental | Biological: Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture linePatients with prolonged postoperative air leaks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- Patients who will be subjected to programmed anatomic lung resection (pneumonectomy excluded)
- Patients class C or D on the risk scale of air leak Patients included in the study must meet all inclusion criteria.
Key exclusion criteria (8 listed)
- Patients with any of the following exclusion criteria may not be included in the clinical trial:
- Those considered by the investigator are not on a good position to tolerate the procedure
- Clinical criteria and anesthetics that contraindicate surgery
- Uncontrolled severe disease
- Pregnant women
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 |
|---|---|---|
| Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture linePatients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro | Biological | Prolonged postoperative air leaks in risk patients. |
Primary outcome
Safety of the procedure
Time frame: During the procedure and postoperative period (48 hours)
Security is measured in terms of: Adverse effects derived from the implantation of the CSM
1 secondary outcome
Analyze the efficacy of the procedure
Time frame: Postoperative period (48 hours), 1 month, 3 months, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Derived from this study: PubMed 37904229Jimenez MF, Gomez-Hernandez MT, Villaron EM, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded with Tissucol Duo(R) for prevention of air leak after anatomical lung resection: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2023 Oct 31;14(1):313. doi: 10.1186/s13287-023-03545-8.
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.
Marcelo F Jiménez López, Ph.D principal investigator
University Clinical Hospital of Salamanca
Gonzalo Varela Simó, Ph.D study chair
University Clinical Hospital of Salamanca
Nuria M Novoa Valentín, Ph.D study chair
University Clinical Hospital of Salamanca
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 Implantation of autologous mesenchymal stem cells (CSM) expanded "in vitro" and administered directly into the lung suture line in people with Postoperative Air Leaks in Risk Patients, run by Red de Terapia Celular at 1 site in Spain.
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 3 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 30 Mar 2017. 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 Spain. 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 Fermín Sánchez-Guijo Martín, Ph.D (+34923294624, ferminsg@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the procedure (time frame: During the procedure and postoperative period (48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045745, which also lists 1 linked publication.
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 30 Mar 2017.