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History of Changes for Study: NCT01885819
Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis
Latest version (submitted August 8, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 20, 2013 None (earliest Version on record)
2 October 29, 2013 Study Status and Contacts/Locations
3 July 3, 2014 Study Status
4 July 30, 2014 Contacts/Locations and Study Status
5 August 1, 2014 Study Status and Contacts/Locations
6 September 25, 2014 Study Status and Oversight
7 January 21, 2015 Recruitment Status, Study Status and Contacts/Locations
8 September 15, 2015 Recruitment Status, Study Status and Study Design
9 April 26, 2017 Study Status
10 August 8, 2017 Study Status
Comparison Format:

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Study NCT01885819
Submitted Date:  June 20, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: TBS-SVF-AR-002-2013
Brief Title: Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2013
Overall Status: Recruiting
Study Start: June 2013
Primary Completion: July 2014 [Anticipated]
Study Completion: December 2015 [Anticipated]
First Submitted: June 18, 2013
First Submitted that
Met QC Criteria:
June 20, 2013
First Posted: June 25, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 20, 2013
Last Update Posted: June 25, 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: 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.

Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Keywords: Adipose stromal vascular fraction
Rheumatoid arthritis
adult 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: Treatment
Autologous stromal vascular fraction cells
Biological: Autologous stromal vascular fraction cells
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
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.

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

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Open or close this module Contacts/Locations
Central Contact Person: Aileen Batista
Telephone: +507 306-2600
Email: abatista@cellmedicine.com
Study Officials: Jorge Paz-Rodriguez, MD
Principal Investigator
Stem Cell Institute
Locations: Panama
Stem Cell Institute
[Recruiting]
Panama City, Panama
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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