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Rheumatoid ArthritisPhase 1/2NCT01885819

Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis

A Phase 1/2 study testing Autologous stromal vascular fraction cells in people with Rheumatoid Arthritis, run by Translational Biosciences at 1 site in Panama.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Autologous stromal vascular fraction cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 sitePanama
Study dates
Jun 2013to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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
  • -

Trial locations and contacts

1 site in 1 country.

Panama1 site

  • Stem Cell Institute

    Panama City

Other trials in Panama

About this study

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

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.

Read the 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.

Being tested
Autologous stromal vascular fraction cells
Keywords
Adipose stromal vascular fraction, Rheumatoid arthritis, adult stem cells
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous stromal vascular fraction cellsBiological

Study groups in NCT01885819
Study groupRoleWhat they receive
TreatmentExperimentalAutologous stromal vascular fraction cells
Receives: Biological: Autologous stromal vascular fraction cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: 6 months

Secondary outcomes (7)

  1. Change from baseline 28-DAS Score at 6 months

    Measured: 6 months

  2. Change from baseline EULAR Response Criteria at 6 months

    Change in European League against Rheumatism (EULAR) response criteria and immunological parameters from baseline to 6 months.

    Measured: 6 months

  3. Change from baseline quality of life measure (based on Stanford HAQ) at 6 months

    Measured: 6 months

  4. Change from baseline C-reactive protein at 6 months

    Measured: 6 months

  5. Change from baseline erythrocyte sedimentation rate (ESR) at 6 months

    Measured: 6 months

  6. Change from baseline anti-citrulline antibody measure at 6 months

    Measured: 6 months

  7. Change from baseline rheumatoid factor (RF) at 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Why it stopped: per sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01885819
Sponsor's protocol ID
TBS-SVF-AR-002-2013
Status last verified
Aug 2017
First submitted
18 Jun 2013
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous stromal vascular fraction cells in people with Rheumatoid Arthritis, run by Translational Biosciences at 1 site in Panama.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01885819.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.

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