Status:
WITHDRAWN
Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis
Lead Sponsor:
Translational Biosciences
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is 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 autologous stromal vascular fraction (SVF) cells administered to 20 patients with disease modifying antirheumatic dr...
Eligibility Criteria
Inclusion
- 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.
- Nonresponsive 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
- 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
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Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01885819
Start Date
June 1 2013
End Date
December 1 2016
Last Update
August 10 2017
Active Locations (1)
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1
Stem Cell Institute
Panama City, Panama