Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

NCT01985464 | Unknown Phase 1 DMC

• 1 other identifier: TBS-UCMSCRA-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; umbilical cord; mesenchymal; stem cells

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  12 months

Secondary Outcomes (7)

• Number of participants with a change in disease activity index as measured by 28-DAS Score

  12 months

• Number of participants with a change in current disease activity as measured by EULAR Response Criteria

  12 months

• Change from baseline quality of life measure (based on Stanford HAQ)

  12 months

• Change from baseline C-reactive protein

  12 months

• Change from baseline erythrocyte sedimentation rate (ESR)

  12 months

Study Arms (1)

Umbilical cord mesenchymal stem cells

EXPERIMENTAL

Biological: Umbilical cord mesenchymal stem cells

Interventions

Umbilical cord mesenchymal stem cells BIOLOGICAL

Umbilical cord mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Biosciences: lead

Study Sites (1)

Stem Cell Institute

Panama City, Panama

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gerardo Castrellon, MD

  Not Affiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 20, 2019

Record last verified: 2018-10

Locations

PA (1)