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History of Changes for Study: NCT01985464
Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Latest version (submitted June 19, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 8, 2013 None (earliest Version on record)
2 July 3, 2014 Study Status
3 July 30, 2014 Contacts/Locations and Study Status
4 August 1, 2014 Study Status and Contacts/Locations
5 September 25, 2014 Study Status and Oversight
6 September 15, 2015 Contacts/Locations and Study Status
7 February 4, 2016 Study Status
8 October 17, 2016 Recruitment Status, Study Status, Contacts/Locations and Eligibility
9 April 26, 2017 Recruitment Status, Study Status and Contacts/Locations
10 August 8, 2017 Contacts/Locations and Study Status
11 January 24, 2018 Recruitment Status, Study Status and Contacts/Locations
12 September 10, 2018 Study Status
13 October 18, 2018 Recruitment Status, Study Status and Contacts/Locations
14 June 19, 2019 Recruitment Status, Study Status and Contacts/Locations
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Study NCT01985464
Submitted Date:  November 8, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: TBS-UCMSCRA-001
Brief Title: Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Official Title: Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2013
Overall Status: Recruiting
Study Start: October 2013
Primary Completion: December 2015 [Anticipated]
Study Completion: June 2016 [Anticipated]
First Submitted: October 31, 2013
First Submitted that
Met QC Criteria:
November 8, 2013
First Posted: November 15, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 8, 2013
Last Update Posted: November 15, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Translational Biosciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
umbilical cord
mesenchymal
stem cells
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Umbilical cord mesenchymal stem cells Biological: Umbilical cord mesenchymal stem cells
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of participants with adverse events
[ Time Frame: 12 months ]

Secondary Outcome Measures:
1. Number of participants with a change in disease activity index as measured by 28-DAS Score
[ Time Frame: 12 months ]

2. Number of participants with a change in current disease activity as measured by EULAR Response Criteria
[ Time Frame: 12 months ]

3. Change from baseline quality of life measure (based on Stanford HAQ)
[ Time Frame: 12 months ]

4. Change from baseline C-reactive protein
[ Time Frame: 12 months ]

5. Change from baseline erythrocyte sedimentation rate (ESR)
[ Time Frame: 12 months ]

6. Change from baseline anti-citrulline antibody measure
[ Time Frame: 12 months ]

7. Change from baseline rheumatoid factor (RF)
[ Time Frame: 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age older than 18 years and ability to understand the planned treatment.
  • Patients of either gender with RA with a duration of 6 to 72 months defined as the presence of at least three of the following criteria: 6 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 human chorionic gonadotropin (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, alanine aminotransferase/aspartate aminotransferase 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 Non-Hodgkin's Lymphoma (NHL), myelodysplastic syndrome (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., erythropoietin (EPO), granulocyte colony stimulating factor (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
Open or close this module Contacts/Locations
Study Officials: Jorbe Paz-Rodriguez, MD
Principal Investigator
Translational Biosciences / Stem Cell Institute
Locations: Panama
Stem Cell Institute
[Recruiting]
Panama City, Panama
Contact:Contact: Aileen Batista +507 306-2600 trials@translationalbiosciences.com
Contact:Principal Investigator: Jorge Paz-Rodriguez, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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