We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Adipose Tissue Stromal Vascular Fraction 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: NCT01885819
Recruitment Status : Withdrawn (per sponsor decision)
First Posted : June 25, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Translational Biosciences

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date August 10, 2017
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Number of participants with adverse events [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • Change from baseline 28-DAS Score at 6 months [ Time Frame: 6 months ]
  • Change from baseline EULAR Response Criteria at 6 months [ Time Frame: 6 months ]
    Change in European League against Rheumatism (EULAR) response criteria and immunological parameters from baseline to 6 months.
  • Change from baseline quality of life measure (based on Stanford HAQ) at 6 months [ Time Frame: 6 months ]
  • Change from baseline C-reactive protein at 6 months [ Time Frame: 6 months ]
  • Change from baseline erythrocyte sedimentation rate (ESR) at 6 months [ Time Frame: 6 months ]
  • Change from baseline anti-citrulline antibody measure at 6 months [ Time Frame: 6 months ]
  • Change from baseline rheumatoid factor (RF) at 6 months [ Time Frame: 6 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 Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis
Official Title  ICMJE Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
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 drug (DMARD)-resistant Rheumatoid Arthritis (RA) who have been nonresponsive 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 1, 2, 3 and 6 of efficacy endpoints of CRP, ESR, anti-citrulline antibody, 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 Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Autologous stromal vascular fraction cells
Study Arms  ICMJE Experimental: Treatment
Autologous stromal vascular fraction cells
Intervention: Biological: Autologous stromal vascular fraction 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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2013)
20
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 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 NCT01885819
Other Study ID Numbers  ICMJE TBS-SVF-AR-002-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Translational Biosciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Translational Biosciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Paz-Rodriguez, MD Stem Cell Institute
PRS Account Translational Biosciences
Verification Date August 2017

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