GVHDPhase 3GvHDNCT06469411
Effect of PMSCs and Their Secretome for the Treatment of GvHD
A Phase 3 study testing Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) and 4 cc distilled water dissolved in albumin 20% in people with GVHD, run by Tabriz University of Medical Sciences at 1 site in Iran.
Trial summary
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- GVHD
- What is being tested?
- Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) and 4 cc distilled water dissolved in albumin 20%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2023to 30 Jan 2024
- Phase
- Phase 3
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with acute GvHD with fever and requiring hospitalization
Who cannot join
- Patients with sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD: A Randomized Clinical Trial
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.
Read the detailed description
This study is a safety, feasibility, and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center. During the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. If they are eligible, they were asked to attend the Ghazi Hospital if they wish to participate in the study. In the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (Food record), and family members. At the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS (Random Allocation Software) and allocation ratio 1:1 to two groups receiving intravenous secretome with The first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. Participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. The secretome of both groups was the same.
- Conditions
- GVHD
- Being tested
- Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter), 4 cc distilled water dissolved in albumin 20%
- Keywords
- Bone marrow, Mesenchymal stem cell, Secretome, Severe Graft-versus-host disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)Biological
Patients in the intervention arm received 6 doses of secretome of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) 4 cc dissolved in albumin 20% every week for 6 weeks
4 cc distilled water dissolved in albumin 20%Other
Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Recipient of 6 doses secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It was produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks Receives: Biological: Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) |
| Control group | Placebo comparator | Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks Receives: Other: 4 cc distilled water dissolved in albumin 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver involvement
Measurement of Bilirubin level
Measured: At the beginning of the study and 6 weeks after the intervention
Intestine condition
Diarrhea volume measurement
Measured: At the beginning of the study and 6 weeks after the intervention
Skin rash
Determination of BSA percentage
Measured: At the beginning of the study and 6 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this clinical trial study, 60 patients with GvHD, who were referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 groups of 30 people, and the intervention and control groups received secretome and distilled water by injection, respectively. The method of blinding was tripleblinded and all the names and personal information of the patients was coded at the time of data collection and remain completely confidential.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- SCARM Institute, Tabriz, Iran
- Responsible party
- Principal investigator, Abolfazl Barzegari, SCARM Institute, Tabriz, Iran
- Investigators
- Hossein Ghasemi Moghadam, MD, Principal investigator, Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, IranSepideh Zununi Vahed, PhD, Study director, Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, IranBabak Nejati, MD, Study director, Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, IranGraciela Pavon-Djavid, PhD, Study chair, Université Sorbonne Paris Nord, INSERM U1148, Laboratory for Vascular Translational Science, Cardiovascular Bioengineering, 99 Av. Jean-Baptiste Clément 93430 Villetaneuse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469411
- Sponsor's protocol ID
- IRCT20201108049311N7
- Other IDs
- 71647
- Acronym
- GvHD
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06469411
- Acronym / sponsor ID
- GvHD / IRCT20201108049311N7
- Conditions
- GVHD
- Keywords
- Bone marrow, Mesenchymal stem cell, Secretome, Severe Graft-versus-host disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tabriz University of Medical SciencesUniversity, hospital or other
- Collaborators
- SCARM Institute, Tabriz, Iran
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 21 Jun 2024 (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.
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.
Detailed description
This study is a safety, feasibility, and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center. During the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. If they are eligible, they were asked to attend the Ghazi Hospital if they wish to participate in the study. In the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (Food record), and family members. At the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS (Random Allocation Software) and allocation ratio 1:1 to two groups receiving intravenous secretome with The first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. Participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. The secretome of both groups was the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this clinical trial study, 60 patients with GvHD, who were referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 groups of 30 people, and the intervention and control groups received secretome and distilled water by injection, respectively. The method of blinding was tripleblinded and all the names and personal information of the patients was coded at the time of data collection and remain completely confidential.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)Recipient of 6 doses secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It was produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks |
| Control group | Placebo comparator | Other: 4 cc distilled water dissolved in albumin 20%Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with acute GvHD with fever and requiring hospitalization
Key exclusion criteria (1 listed)
- Patients with sepsis
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 |
|---|---|---|
| Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)Patients in the intervention arm received 6 doses of secretome of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) 4 cc dissolved in albumin 20% every week for 6 weeks | Biological | Intervention group |
| 4 cc distilled water dissolved in albumin 20%Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks | Other | Control group |
Primary outcome
Liver involvement
Time frame: At the beginning of the study and 6 weeks after the intervention
Measurement of Bilirubin level
Intestine condition
Time frame: At the beginning of the study and 6 weeks after the intervention
Diarrhea volume measurement
Skin rash
Time frame: At the beginning of the study and 6 weeks after the intervention
Determination of BSA percentage
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 21 Jun 2024.
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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.
Hossein Ghasemi Moghadam, MD principal investigator
Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran
Sepideh Zununi Vahed, PhD study director
Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Babak Nejati, MD study director
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) and 4 cc distilled water dissolved in albumin 20% in people with GVHD, run by Tabriz University of Medical Sciences at 1 site in Iran.
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: finished, as of the sponsor's last update on 21 Jun 2024. 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 Iran. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Liver involvement (time frame: At the beginning of the study and 6 weeks after the intervention). The study lists 3 primary outcomes in all. 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 21 Jun 2024.