A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis

Mesoblast, Inc0 个研究点目标入组 90 人开始时间: 2013年9月13日最近更新: 2014年2月17日

研究概览

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•- Provision of informed consent
•- Males and females 18 - 80 years of age.
•- Active rheumatoid arthritis (RA) diagnosed according to the 2010 ACR/EULAR classification criteria. Patients must be positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP3) antibodies and must have early (6 months – 2 years disease duration) RA but without the poor prognostic features of functional limitation or extra-articular disease.
•- Patients must have:
•> 4 tender joints (TJC) count (28 joint count) at screening and
•> 4 swollen joint (SJC) count (28 joint count) at screening
•Erythrocyte sedimentation rate (ESR) > 28 mm/hr OR hsCRP greater than ULN.
•- Patient has been taking at least one and up to 3 synthetic oral DMARDS as combination therapy for at least 6 months, of which the 8 weeks preceding enrollment were at stable dose and route of administration between 15 and 25 mg/week for MTX, and the patient has not had adequate response as determined by the investigator and findings as specified above.
•- Women of child bearing potential must use effective contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Use of more than 3 synthetic oral DMARDs.
•- Prior use of anti-TNF or other biologic for treatment of rheumatoid arthritis at any point prior to screening.
•- Other investigational therapy received within 8 weeks or five half-lives (whichever is longer) prior to Screening or any prior regenerative therapy treatments (including participation in any stem cell or regenerative medicine study)
•- Pregnant or breast-feeding.
•- Autoimmune disease other than RA
•- History of or current inflammatory joint disease other than RA.
•- Bedridden or confined to a wheelchair or patients who have had > 3 arthroplasties due to RA.
•- Known hypersensitivity to dimethyl sulfoxide (DMSO), murine or bovine protein.
•- Prior treatment with any cell-depleting therapies including investigational agents.
•- Gold compounds if less than 8 weeks prior to randomization; immunoadsorption columns if less than 6 months prior to baseline.
•- QTc = 450 ms for males and QTc = 470 ms for females at Screening.

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