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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 July 2023 |
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Main ID: |
NCT03186417 |
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Date of registration:
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12/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mesenchymal Stem Cells in Early Rheumatoid Arthritis
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Scientific title:
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Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial |
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Date of first enrolment:
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December 15, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03186417 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Nora singer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MetroHealth Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-80 years
- Recent onset rheumatoid arthritis and have known doctor diagnosis = 2 years and
symptoms for = 2 years.
- Patients must have detectable serum auto-antibodies against cyclic citrullinated
peptides and/or high titer serum rheumatoid factor at screening or prior to screening.
- Subjects must have active synovitis of at least one joint.
- Patients who have been intolerant or had inadequate response to at least twelve weeks
total of methotrexate, ten weeks of which methotrexate must have been dosed at =15 mg
per week or with low dose steroids (< 10 mg prednisone per day).
- Clinically stable with no significant changes in health status within 2 weeks prior to
randomization
Exclusion Criteria:
- Prior use of DMARDs other than non-steroidals, low dose prednisone, hydroxychloroquine
and methotrexate
- Use of leflunomide or sulfasalazine for more than 3 days and less than 3 half lives
have passed since discontinuing. For leflunomide, wash out is permissible.
- Prior use of Biologic DMARDs
- Presence of active infection
- History of chronic viral infections including Hepatitis B or C or HIV. Treated
Hepatitis C is allowed if the viral in non-detectable
- Known chronic liver disease
- Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth
control during participation in the study and for twelve months after completing the
study infusion, unless surgically sterilized or postmenopausal during the study.
- Active tuberculosis (TB) requiring treatment within 3 years prior to baseline
- Latent TB diagnosed during screening that has not been appropriately treated
- History of Cancer requiring chemotherapy within the past 5 years except Human
Papillomavirus (HPV) related cervical changes that are not carcinoma in situ.
- Chronic obstructive pulmonary disease or known lung disease except for mild asthma
treated with bronchodilators.
- Use of an investigational agent within the 4-week period prior to screen
- If Dimethyl sulfoxide (DMSO) is used in the preparation of MSCs then subjects with
known sensitivity to DMSO will be excluded
- History of Transient Ischemic Attack
- History of Cerebrovascular Accident (stroke), unless there has been no CVA for > or =
1 year after the resolution of the underlying cause of the CVA
- Clinically significant heart disease (New York Heart Association, class III and class
IV).
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Biological: 6 million hMSC/kg
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Biological: 2 million hMSC/kg
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Biological: 4 million hMSC/kg
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Biological: placebo
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Primary Outcome(s)
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Safety assessed by all adverse events
[Time Frame: 52 weeks following infusion]
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Safety assessed by dose limiting toxicity (DLT)
[Time Frame: 14 days following infusion]
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Safety assessed by change in spirometry
[Time Frame: 30 minutes following infusion]
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Safety assessed by dose limiting toxicity
[Time Frame: 48 hours following infusion]
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Secondary Outcome(s)
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Change in patient reported outcomes
[Time Frame: Up to day 28 after infusion]
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DAS28-CRP
[Time Frame: Week 52]
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Secondary ID(s)
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IRB16-00587
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R21AR069226
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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