Acute Graft Versus Host DiseasePhase 1/2NCT02687646
Clinical Trial With MSC for Graft Versus Host Disease Treatment
A Phase 1/2 study testing Adult Allogeneic Mesenchymal cells from adipose tissue. in people with Acute Graft Versus Host Disease, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 6 sites in Spain.
Trial summary
Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Graft Versus Host Disease
- What is being tested?
- Adult Allogeneic Mesenchymal cells from adipose tissue.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesSpain
- Study dates
- 20 Feb 2017to 21 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
- Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
- Having been transplanted with myeloablative or non-myeloablative conditioning.
- normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
- Lung function without evidence of severe obstructive or restrictive lung disease.
- Age between 18 and 65 years.
Show all 9Show fewer
- Women of childbearing age considered until one year after the last menstrual period and which have not undergone a surgical sterilization must obtain a negative pregnancy test at the time of inclusion in the study and commit to use a medically approved birth control while on study.
- normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
- Signature of informed consent -
Who cannot join
- uncontrolled blood disorder by transplantation or progression at the time of inclusion.
- bacterial, viral, fungal or is not being controlled.
- Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
- Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
- Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
- positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitario Reina Sofía
Córdoba
Hospital Regional Universitario de Málaga
Málaga
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Clinica Universitaria de Navarra, Av Pio XII ,36
Pamplona, Navarre, 31008
Hospital clinico universitario de salamanca
Salamanca, 37007
Virgen del Rocio University Hospital, av. Manuel Siurot s/n
Seville, 41013
About this study
Official title: Clinical Trial Phase I / II Graft Versus Host Disease Treatment Refractory to First-line Therapy With Sequential Infusion of Mesenchymal Cells Allogeneic Expanded Adipose Tissue in Vitro
Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.
Read the detailed description
Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell trasplantation, who have developed a refractory graft versus host disease to first line of treatment.
This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.
- Conditions
- Acute Graft Versus Host Disease
- Being tested
- Adult Allogeneic Mesenchymal cells from adipose tissue.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Allogeneic Mesenchymal cells from adipose tissue.Drug
Also called MSC for the treatment of graft -versus -host disease
Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products.
Subjects will receive four sequential IV dose of Mesenchymal stem cells.
Sequential doses:
Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Mesenchymal Cells | Experimental | All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group. Receives: Drug: Adult Allogeneic Mesenchymal cells from adipose tissue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by incidence of serious adverse events
Safety will be measured in terms of:
Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.
Measured: 2 years
Secondary outcomes (1)
Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment
Effectiveness will be measured in terms of:
Answer of refractory acute graft disease against host to first-line treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study start20 Feb 2017
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Initiative for Advanced Therapies
- Responsible party
- Sponsor
- Investigators
- Teresa Caballero, Hematologist, Study director, Virgen del Rocio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687646
- Sponsor's protocol ID
- MSC-EICH-2014
- Other IDs
- 2014-005533-32, 2014
- Status last verified
- Oct 2022
- First submitted
- 19 Jan 2016
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase I / II Graft Versus Host Disease Treatment Refractory to First-line Therapy With Sequential Infusion of Mesenchymal Cells Allogeneic Expanded Adipose Tissue in Vitro
- ClinicalTrials.gov ID
- NCT02687646
- Acronym / sponsor ID
- MSC-EICH-2014
- Conditions
- Acute Graft Versus Host Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Andalusian Initiative for Advanced Therapies
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 22 Feb 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.
Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.
Detailed description
Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell trasplantation, who have developed a refractory graft versus host disease to first line of treatment.
This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Mesenchymal Cells | Experimental | Drug: Adult Allogeneic Mesenchymal cells from adipose tissue.All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
- Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
- Having been transplanted with myeloablative or non-myeloablative conditioning.
- normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
- Lung function without evidence of severe obstructive or restrictive lung disease.
Key exclusion criteria (6 listed)
- uncontrolled blood disorder by transplantation or progression at the time of inclusion.
- bacterial, viral, fungal or is not being controlled.
- Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
- Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
- Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
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 |
|---|---|---|
| Adult Allogeneic Mesenchymal cells from adipose tissue.Also: MSC for the treatment of graft -versus -host diseaseStudy treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products. Subjects will receive four sequential IV dose of Mesenchymal stem cells. Sequential doses: Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg | Drug | Allogeneic Mesenchymal Cells |
Primary outcome
Safety measured by incidence of serious adverse events
Time frame: 2 years
Safety will be measured in terms of: Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.
1 secondary outcome
Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment
Time frame: 2 years
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 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Teresa Caballero, Hematologist study director
Virgen del Rocio University Hospital
6 sites 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 Adult Allogeneic Mesenchymal cells from adipose tissue. in people with Acute Graft Versus Host Disease, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 6 sites 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 9 inclusion and 6 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Safety measured by incidence of serious adverse events (time frame: 2 years). 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 13 Oct 2022.