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Trial record 6 of 157 for:    stem cell arthritis AND Arthritis

Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01985464
Recruitment Status : Active, not recruiting
First Posted : November 15, 2013
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Tracking Information
First Submitted Date  ICMJE October 31, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date June 20, 2019
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
Number of participants with adverse events [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01985464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Official Title  ICMJE Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
Brief Summary Allogeneic human umbilical cord tissue-derived stem cells will be injected intravenously once per day for 5 days is a safe and useful procedure in inducing remission of RA in patients resistant to standard DMARD therapy.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Umbilical cord mesenchymal stem cells
Study Arms  ICMJE Experimental: Umbilical cord mesenchymal stem cells
Intervention: Biological: Umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985464
Other Study ID Numbers  ICMJE TBS-UCMSCRA-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Translational Biosciences
Study Sponsor  ICMJE Translational Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerardo Castrellon, MD Not Affiliated
PRS Account Translational Biosciences
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP