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Stem cells

Phase 3

Rheumatoid Arthritis Aggravated | Cell therapy | Immunology |Takeda Pharmaceutical Company Limited|Last Updated: Apr 12, 2019

Development status

Highest phase Phase 3 run by Hackensack Meridian Health (NCT01877837)
Phase scored for TAKPhase 1
Registered trials 2 across 2 sponsors since Aug 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

Stem cells · 1 trial · 1 indication

Phase 1 1
NCT01663116Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis PatientsRheumatoid Arthritis Aggravated
COMPLETED53 Analytics
PHASE1COMPLETED
Cx611-0101, eASCs Intravenous Administration to Refractory Rheumatoid Arthritis Patients
Rheumatoid Arthritis Aggravated
NCT0166311653
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Study Endpoints

Primary Endpoints

Number of Adverse Events and Severe Adverse Events
6 months follow up after the first administration

Total number of Adverse Events and Severe Adverse Events, related and non-related with the medication will be recorded as a measure of tolerability and safety.

Secondary Endpoints

Proportion of ACR20 patients/ACR50 patients/ACR70 patients (swollen joints*, tender joints**, physician global assessment***, patient global assessment***, patient´s assessment of pain ***, ESR/CRP, HAQ score)
At selection and screening visit, and once per month during 6 months after the last administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTAL1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15 2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15 3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15
PlaceboPLACEBO_COMPARATORLactate Ringer´s solution

Interventions

NameTypeDescription
Stem cellsGENETIC1. first cohort: 1 million stem cells/kg administered at days 1, 8 and 15 2. second cohort: 2 million stem cells / kg administered at days 1, 8 and 15 3. third cohort: 4 million stem cells / kg administered at days 1, 8 and 15
PlaceboGENETIC1. first cohort: 20 ml administered at days 1, 8 and 15 2. second cohort: 40 ml administered at days 1, 8 and 15 3. third cohort: 80 ml administered at days 1, 8 and 15
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion criteria Patients must meet all the following inclusion criteria to be eligible for study entry: 1. Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures. 2. Subjects with RA under treatment with at least one non-bio...

Countries:Spain
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