Rheumatoid ArthritisNCT03798028
The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
A study testing UC-MSCs in people with Rheumatoid Arthritis, run by Xijing Hospital at 1 site in China.
Trial summary
This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2017to 30 Jun 2020
- Phase
- Interventional
- 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
- Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
- Age limits:18 to 70 years old.
- Freely given informed consent.
- Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0.
- Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
- Poor response to current treatment. The current treatment refers to receive the medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine, Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain the stable-dose of drugs for at least 1 month.
- More than 3 months and a stable dose for at least 1 month are required if glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day of prednisone.
Who cannot join
- Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
- Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
- Complication with other connective tissue disease (except for Sjogren syndrome) .
- Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
- Participants with acute and chronic tuberculosis infection.
- Malignant tumors or participants with a family history of malignant tumors.
Show all 21Show fewer
- Participants have a family history of allergic conditions.
- Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus （HIV）.
- Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
- Participants received live vaccines with 3 months.
- Drug abuse and alcoholism.
- Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
- Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
- Participants received stem cell therapy in the past.
- Participants received any biological agents within 3 months.
- Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
- Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
- Participants taking drugs that affect the test for blood and lung.
- Participants taking any traditional Chinese medicine.
- Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
- Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Ping Zhu, 862984773951 ext. 862984773951, zhuping@fmmu.edu.cn
About this study
Official title: The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study
This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
- Conditions
- Rheumatoid Arthritis
- Being tested
- UC-MSCs
- Keywords
- anemia, Interstitial pulmonary disease
- Medical subject headings
- Arthritis, Rheumatoid, Anemia, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
Also called placebo
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs treatment | Experimental | the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment. Receives: Biological: UC-MSCs |
| no UC-MSCs treatment | No intervention | the participants will receive the placebo in combined with the present treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
The HGB increases by 10g compared to the baseline is considered improvement.
Measured: 24 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
Measured: 24 weeks
Secondary outcomes (6)
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
Measured: 12 weeks and 24 weeks
White blood cell count and platelet count improved compared to the baseline.
White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
Measured: 12 weeks and 24 weeks
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
The HGB increases by 10 g compared to the baseline is considered improvement.
Measured: 12 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
FVC increases by 0.5% and DLCO increases by 10% compared to baseline
Measured: 12 weeks
Image improvement of lung on high resolution CT.
The area change of image of lung.
Measured: 24 weeks
Improvement of 6-minute walking distance compared to baseline.
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start26 Dec 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Southwest Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798028
- Sponsor's protocol ID
- 2014ZX09508002
- Status last verified
- Dec 2018
- First submitted
- 7 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03798028
- Acronym / sponsor ID
- 2014ZX09508002
- Conditions
- Rheumatoid Arthritis
- Keywords
- anemia, Interstitial pulmonary disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Southwest Hospital, China
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Jan 2019 (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 evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs treatment | Experimental | Biological: UC-MSCsthe participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment. |
| no UC-MSCs treatment | No intervention | –the participants will receive the placebo in combined with the present treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
- Age limits:18 to 70 years old.
- Freely given informed consent.
- Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0.
- Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
Key exclusion criteria (21 listed)
- Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
- Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
- Complication with other connective tissue disease (except for Sjogren syndrome) .
- Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
- Participants with acute and chronic tuberculosis infection.
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 |
|---|---|---|
| UC-MSCsAlso: placeboThe UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg. | Biological | UC-MSCs treatment |
Primary outcome
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Time frame: 24 weeks
The HGB increases by 10g compared to the baseline is considered improvement.
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
Time frame: 24 weeks
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
6 secondary outcomes
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
Time frame: 12 weeks and 24 weeks
White blood cell count and platelet count improved compared to the baseline.
Time frame: 12 weeks and 24 weeks
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Time frame: 12 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
Time frame: 12 weeks
Image improvement of lung on high resolution CT.
Time frame: 24 weeks
Improvement of 6-minute walking distance compared to baseline.
Time frame: 12 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSCs in people with Rheumatoid Arthritis, run by Xijing Hospital 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 21 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 9 Jan 2019. 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.
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 Ping Zhu, Doctor (86-29-84773951, zhuping@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of blood routine hemoglobin (HGB) compared to baseline. (time frame: 24 weeks). The study lists 2 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 9 Jan 2019.