Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01985464|
Recruitment Status : Unknown
Verified October 2018 by Translational Biosciences.
Recruitment status was: Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : June 20, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Umbilical cord mesenchymal stem cells||Phase 1 Phase 2|
The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic UC-MSC administered to 20 patients with disease modifying antirheumatic drug (DMARD)-resistant Rheumatoid Arthritis (RA) who have been non-responsive to at least one course of one DMARD selected from a group comprising of: gold salts, leflunomide, methotrexate, and hydroxychloroquine.
The primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 3 and 12 of efficacy endpoints of C reactive protein (CRP), erythrocyte sedimentation rate (ESR), anti-citrulline antibody, rheumatoid factor (RF), Quality of Life Questionnaire, 28-joint disease activity score (DAS28), European League against Rheumatism (EULAR) response criteria and immunological parameters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
|Experimental: Umbilical cord mesenchymal stem cells||
Biological: Umbilical cord mesenchymal stem cells
- Number of participants with adverse events [ Time Frame: 12 months ]
- Number of participants with a change in disease activity index as measured by 28-DAS Score [ Time Frame: 12 months ]
- Number of participants with a change in current disease activity as measured by EULAR Response Criteria [ Time Frame: 12 months ]
- Change from baseline quality of life measure (based on Stanford HAQ) [ Time Frame: 12 months ]
- Change from baseline C-reactive protein [ Time Frame: 12 months ]
- Change from baseline erythrocyte sedimentation rate (ESR) [ Time Frame: 12 months ]
- Change from baseline anti-citrulline antibody measure [ Time Frame: 12 months ]
- Change from baseline rheumatoid factor (RF) [ Time Frame: 12 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Signed inform consent by the subject.
- Age older than 18 years and ability to understand the planned treatment.
- Patients of either gender with RA with a duration of 6 months to 20 years defined as the presence of at least three of the following criteria: 3 or more painful, 2 or more swollen joints, morning stiffness for at least 45 minutes (on average during the week prior to entry), and an erythrocyte sedimentation rate (ESR) of at least 28 mm.
- Non-responsive to at least one course of one DMARD selected from the group comprising of: gold salts, leflunomide, methotrexate, and hydroxychloroquine.
- Second-line agents are discontinued at least 4 weeks prior to entry.
- Able to tolerate ALL study procedures
- Able to give informed Consent
- Negative for HcG with a serum pregnancy test
- Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
- Life expectancy of 6 months or more in the opinion of the investigator
- Serum bilirubin, ALT, AST up to 2.5 time the upper level of normal.
- Controlled blood pressure (systolic blood pressure ≤140 and a diastolic blood pressure of ≤90 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
- Patient has received stable, standard medical therapy for at least one month with no new medications to treat the disease introduced in the last month.
- Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia) are adequately controlled in the opinion of the investigator
- Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.
- Female who is pregnant or nursing, or of child-bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
- History of prior radiation exposure for oncological treatment.
- History of Bone Marrow Disorder (especially NHL, MDS)
- History of abnormal bleeding or clotting.
- History of Liver Cirrhosis.
- End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
- Active clinical infection being treated by antibiotics before one week enrollment
- Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
- History of life-threatening arrhythmias, except if an automated implantable cardioverter defibrillator (AICD) is implanted
- Life expectancy <6 months due to concomitant illnesses
- Known cancer and undergoing treatment; chemotherapy and/or radiotherapy
- Patients receiving treatment with hematopoietic growth factors (e.g., EPO, G-CSF)
- Patients who can not stop anticoagulation therapy (warfarin) 72hrs prior to infusion
- Patients who can not stop anti-platelet therapy (clopidogrel) 7 days prior infusion
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985464
|Stem Cell Institute|
|Panama City, Panama|
|Principal Investigator:||Gerardo Castrellon, MD||Not Affiliated|
|Responsible Party:||Translational Biosciences|
|Other Study ID Numbers:||
|First Posted:||November 15, 2013 Key Record Dates|
|Last Update Posted:||June 20, 2019|
|Last Verified:||October 2018|
Connective Tissue Diseases
Immune System Diseases