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Recruitment Status : Withdrawn (per sponsor decision)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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Autologous stromal vascular fraction cells Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis
Study Start Date : June 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Autologous stromal vascular fraction cells
Biological: Autologous stromal vascular fraction cells



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline 28-DAS Score at 6 months [ Time Frame: 6 months ]
  2. 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.

  3. Change from baseline quality of life measure (based on Stanford HAQ) at 6 months [ Time Frame: 6 months ]
  4. Change from baseline C-reactive protein at 6 months [ Time Frame: 6 months ]
  5. Change from baseline erythrocyte sedimentation rate (ESR) at 6 months [ Time Frame: 6 months ]
  6. Change from baseline anti-citrulline antibody measure at 6 months [ Time Frame: 6 months ]
  7. Change from baseline rheumatoid factor (RF) at 6 months [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885819


Locations
Panama
Stem Cell Institute
Panama City, Panama
Sponsors and Collaborators
Translational Biosciences
Investigators
Principal Investigator: Jorge Paz-Rodriguez, MD Stem Cell Institute

Responsible Party: Translational Biosciences
ClinicalTrials.gov Identifier: NCT01885819     History of Changes
Other Study ID Numbers: TBS-SVF-AR-002-2013
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Translational Biosciences:
Adipose stromal vascular fraction
Rheumatoid arthritis
adult stem cells

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents