Rheumatoid ArthritisPhase 1/2RANCT01547091
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
A Phase 1/2 study testing Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) and UC-MSC+DMARDS in people with Rheumatoid Arthritis, run by Alliancells Bioscience Corporation Limited at 1 site in China.
Trial summary
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. 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?
- Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) and UC-MSC+DMARDS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2014
- 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
- All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
- Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
- Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
Who cannot join
- Any history of ongoing, significant or recurring infections.
- Any active inflammatory diseases other than RA.
- Significant cardiac or pulmonary disease.
- End-stage renal failure.
- Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 323 Hospital of Chinese People's Liberation Army
Xi'an, Shaanxi, 710054
Liming Wang, MD, 86-29-84756502, wanglm@fmmu.edu.cn
Liming Wang, MD
About this study
Official title: Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
Read the detailed description
This study was supported by the National Natural Science Foundation of China (30872618)，The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
- Conditions
- Rheumatoid Arthritis
- Being tested
- Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs), UC-MSC+DMARDS
- Keywords
- Mesenchymal Stem Cells, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)Biological
-The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.
Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)Drug
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
UC-MSC+DMARDSBiological
The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs Treatment | Experimental | Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only. Receives: Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) |
| DMARDS | Active comparator | Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs). Receives: Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) |
| UC-MSC+DMARDS | Active comparator | Patients will be treated in combination with UC-MSC and DMARDS. Receives: Biological: UC-MSC+DMARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MSC treatment.
Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment.
Measured: six months
Secondary outcomes (3)
RA Serology
Rheumatoid Factor, C-reactive protein
Measured: 1, 3 and 6 months
Disease Activity Score (DAS 28) Index Mean Change From Baseline
Measured: 1, 3 and 6 months
Patient's assessment of pain.
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startApr 2013
- Primary completionOct 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliancells Bioscience Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingyuan Wu, MD,PhD, Principal investigator, Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., LtdYongjun Liu, MD,PhD, Principal investigator, Alliancells Biosciences Co., LtdLiming Wang, MD, Study director, The 323 Hospital of Chinese People's Liberation ArmyHaijie Ji, MD, Principal investigator, Alliancells Biosciences Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547091
- Sponsor's protocol ID
- Alliancells-1
- Acronym
- RA
- Status last verified
- Mar 2013
- First submitted
- 22 Feb 2012
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang H, Wu M, Liu Y. Are mesenchymal stem cells major sources of safe signals in immune system? Cell Immunol. 2012;272(2):112-6. doi: 10.1016/j.cellimm.2011.10.010. Epub 2011 Oct 29.
PubMed 22138499Wang L, Ji H, Zhou J, Xie J, Zhong Z, Li M, Bai W, Li N, Zhang Z, Wang X, Zhu D, Liu Y, Wu M. Therapeutic potential of umbilical cord mesenchymal stromal cells transplantation for cerebral palsy: a case report. Case Rep Transplant. 2013;2013:146347. doi: 10.1155/2013/146347. Epub 2013 Mar 3.
PubMed 23533920
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II
- ClinicalTrials.gov ID
- NCT01547091
- Acronym / sponsor ID
- RA / Alliancells-1
- Conditions
- Rheumatoid Arthritis
- Keywords
- Mesenchymal Stem Cells, Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alliancells Bioscience Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 7 Mar 2012 (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.
Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
Detailed description
This study was supported by the National Natural Science Foundation of China (30872618)，The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs Treatment | Experimental | Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only. |
| DMARDS | Active comparator | Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs). |
| UC-MSC+DMARDS | Active comparator | Biological: UC-MSC+DMARDSPatients will be treated in combination with UC-MSC and DMARDS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
- Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
- Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
Key exclusion criteria (5 listed)
- Any history of ongoing, significant or recurring infections.
- Any active inflammatory diseases other than RA.
- Significant cardiac or pulmonary disease.
- End-stage renal failure.
- Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
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 |
|---|---|---|
| Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)-The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion. | Biological | UC-MSCs Treatment |
| Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)-Patients will be treated by conventional drugs (DMARDS) for alleviating disease. | Drug | DMARDS |
| UC-MSC+DMARDSThe UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated. | Biological | UC-MSC+DMARDS |
Primary outcome
Safety of MSC treatment.
Time frame: six months
Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment.
3 secondary outcomes
RA Serology
Time frame: 1, 3 and 6 months
Disease Activity Score (DAS 28) Index Mean Change From Baseline
Time frame: 1, 3 and 6 months
Patient's assessment of pain.
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Background: PubMed 22138499Wang H, Wu M, Liu Y. Are mesenchymal stem cells major sources of safe signals in immune system? Cell Immunol. 2012;272(2):112-6. doi: 10.1016/j.cellimm.2011.10.010. Epub 2011 Oct 29.
- Background: PubMed 23533920Wang L, Ji H, Zhou J, Xie J, Zhong Z, Li M, Bai W, Li N, Zhang Z, Wang X, Zhu D, Liu Y, Wu M. Therapeutic potential of umbilical cord mesenchymal stromal cells transplantation for cerebral palsy: a case report. Case Rep Transplant. 2013;2013:146347. doi: 10.1155/2013/146347. Epub 2013 Mar 3.
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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.
Mingyuan Wu, MD,PhD principal investigator
Eastern Union Stem Cell & Gene Engineering Co.,Ltd，Alliancells Biosciences Co., Ltd
Yongjun Liu, MD,PhD principal investigator
Alliancells Biosciences Co., Ltd
Liming Wang, MD study director
The 323 Hospital of Chinese People's Liberation Army
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 Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs), Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) and UC-MSC+DMARDS in people with Rheumatoid Arthritis, run by Alliancells Bioscience Corporation Limited 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 3 inclusion and 5 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 27 Jun 2013. 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 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 Mingyuan Wu, MD,PhD (86-10-63188123, mingyuan-wu@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of MSC treatment. (time frame: six months). 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 NCT01547091, which also lists 2 linked publications.
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 27 Jun 2013.