Systemic Lupus ErythematosusEarly Phase 1NCT03219801
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Systemic Lupus Erythematosus
A Early Phase 1 study testing mesenchymal stem cells in people with Systemic Lupus Erythematosus, run by Hebei Medical University at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Dec 2019
- Phase
- Early 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997
- Age from 14 to 60 years
- No serious infection or acute hemorrhage
- Left ventricular ejection fraction (LVEF)≥ 50%
- Both transaminase and serum creatinine level are more than twice times the upper limit of normal
- No acute infectious diseases.
- Understanding and willingness to sign a written informed consent document.
Who cannot join
- Patients with SLE have to be disqualified from this study if any of the following is applicable:
- SLE(Systemic lupus erythematosus) with severe infection.
- Severe heart attack, liver and kidney disease following serious complications
- Patients with allergic constitution.
- Pregnancy and breastfeeding women.
- Accompanied by malignant tumors or other malignant disease
- Patients as participant in the other clinical text
- Patients with active tuberculosis, acute sever hepatitis or infectious period of diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus.
Read the detailed description
To ensure that all patients of systemic lupus erythematosus (SLE) completed 6-months follow-up, twenty SLE patients ranging from 14 to 60 years old were enrolled in this trial. Participants matched with the inclusion criteria were allocated randomly into two groups:Human Umbilical Cord Derived Mesenchymal Stem Cells (hUC-MSCs) treated group and control group. Clinical trials are being increasingly established to investigate the therapeutic potential of these cells for SLE. The aim of the present study is to investigate safety and efficacy of vein infusion of allogeneic hUC-MSCs in patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- mesenchymal stem cells
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsBiological
SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Selected SLE patients were randomly divided into treated group and control group. In the treated group, 100-300 million allogeneic human umbilical cord derived mesenchymal stem cells were infused intravenously for one SLE patient. The possible adverse events, including immediately after mesenchymal stem cells infusions, as well as the long-term safety profiles were observed. Receives: Biological: mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Complement levels(C3 and C4) in peripheral blood
The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.
Measured: Post cell transplantation: 1, 3, 6 months
Secondary outcomes (3)
Erythrocyte sedimentation rate
The change of inflammation is evaluated by erythrocyte sedimentation rate.
Measured: Post cell transplantation: 1, 3, 6 months
C-reactive protein
C-reactive protein is an acute phase reactants. It can be moderately increased in in peripheral blood of SLE patients.
Measured: Post cell transplantation: 1, 3, 6 months
adverse reaction
Adverse reaction includes temperature changes(℃), the change of blood pressure(mmHg) and allergic reaction.These measurements were associated with the safety of the intervention.
Measured: Post cell transplantation: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quanhai Li, Hebei Medical University
- Investigators
- Baoyong Yan, Doctor, Study chair, The First Hospital of Hebei Medical UniversityQingchi Liu Liu, Doctor, Study director, The First Hospital of Hebei Medical UniversityQuanhai Li, Doctor, Study director, The First Hospital of Hebei Medical UniversityXiaohui Jia, Doctor, Principal investigator, The First Hospital of Hebei Medical UniversityXianyun Wang, Doctor, Principal investigator, The First Hospital of Hebei Medical UniversityFan Zhang, Bachelor, Principal investigator, The First Hospital of Hebei Medical UniversityYang Shen, Master, Principal investigator, The First Hospital of Hebei Medical UniversityBing Ma, Master, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219801
- Sponsor's protocol ID
- 17277787D-SLE
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 18 Jul 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 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy in Patients With Systemic Lupus Erythematosus by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT03219801
- Acronym / sponsor ID
- 17277787D-SLE
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Jul 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.
This study is to evaluate the safety and efficacy of human umbilical cord derived mesenchymal stem cells transplantation in systemic lupus erythematosus.
Detailed description
To ensure that all patients of systemic lupus erythematosus (SLE) completed 6-months follow-up, twenty SLE patients ranging from 14 to 60 years old were enrolled in this trial. Participants matched with the inclusion criteria were allocated randomly into two groups:Human Umbilical Cord Derived Mesenchymal Stem Cells (hUC-MSCs) treated group and control group. Clinical trials are being increasingly established to investigate the therapeutic potential of these cells for SLE. The aim of the present study is to investigate safety and efficacy of vein infusion of allogeneic hUC-MSCs in patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Biological: mesenchymal stem cellsSelected SLE patients were randomly divided into treated group and control group. In the treated group, 100-300 million allogeneic human umbilical cord derived mesenchymal stem cells were infused intravenously for one SLE patient. The possible adverse events, including immediately after mesenchymal stem cells infusions, as well as the long-term safety profiles were observed. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of SLE(Systemic lupus erythematosus) from American College of Rheumatology(ACR) according to established criteria in 1997
- Age from 14 to 60 years
- No serious infection or acute hemorrhage
- Left ventricular ejection fraction (LVEF)≥ 50%
- Both transaminase and serum creatinine level are more than twice times the upper limit of normal
Key exclusion criteria (8 listed)
- Patients with SLE have to be disqualified from this study if any of the following is applicable:
- SLE(Systemic lupus erythematosus) with severe infection.
- Severe heart attack, liver and kidney disease following serious complications
- Patients with allergic constitution.
- Pregnancy and breastfeeding 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 |
|---|---|---|
| mesenchymal stem cellsSLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect. | Biological | mesenchymal stem cells |
Primary outcome
The change of Complement levels(C3 and C4) in peripheral blood
Time frame: Post cell transplantation: 1, 3, 6 months
The recovery of immunologic function is evaluated by complement levels (g/L) in peripheral blood.
3 secondary outcomes
Erythrocyte sedimentation rate
Time frame: Post cell transplantation: 1, 3, 6 months
C-reactive protein
Time frame: Post cell transplantation: 1, 3, 6 months
adverse reaction
Time frame: Post cell transplantation: 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Baoyong Yan, Doctor study chair
The First Hospital of Hebei Medical University
Qingchi Liu Liu, Doctor study director
The First Hospital of Hebei Medical University
Quanhai Li, Doctor study director
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mesenchymal stem cells in people with Systemic Lupus Erythematosus, run by Hebei Medical University at 1 site in China.
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 18 Jul 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jun Zhang, Master (86-311-85917384, june_luck@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Complement levels(C3 and C4) in peripheral blood (time frame: Post cell transplantation: 1, 3, 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 18 Jul 2017.