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Trial record 3 of 4 for:    stromal vascular fraction for rheumatoid arthritis

Safety and Efficacy of Adipose Derived Stem Cells in Refractory Rheumatoid Arthritis, Systemic Lupus Erythematosus or Sharp's Syndrome

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ClinicalTrials.gov Identifier: NCT02741362
Recruitment Status : Terminated (Primary Investigator no longer with institution)
First Posted : April 18, 2016
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Arkansas Heart Hospital

Brief Summary:

This is a Phase I-II open- label single-dose study in subjects with significant refractory Rheumatoid Arthritis (RA), relapsing Systemic Lupus Erythematosus (SLE) or Sharp's Syndrome (SS).

This study will enroll a minimum of 20 subjects for RA, 20 subjects for SLE and 20 patients for SS. 6 week data of serum Tumor Necrosis Factor- alpha (TNFa), Interleukin- 6 (IL-6), C- Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Cluster of Differentiation (CD)4 +CD25 + Forkhead box P3(Foxp3) + regulatory T cells, Disease Activity Score for 28 joints (DAS-28) score and pain score will be collected in all patients who are enrolled in the study for the RA group (Baseline and 6 weeks after). For the SLE group, Transforming Growth Factor- beta (TGF-β), TNFa, IL-6, Interleukin- 17 (IL-17), CD3+CD8-IL17A+ T helper-17 (Th17) cells, CD4+CD25+Foxp3+ regulatory T cells and the Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQoL) score will be collected in all the subjects of this group. SS group will undergo the assessments of RA and SLE. Prior to the stem cell treatment, the patient will be assessed for 6 weeks by all the previously mentioned markers. Then, patients will receive the infusion of stromal vascular fraction cells containing the adult adipose derived stem cells 'aADSC' (single intravenous dose). The disease- modifying anti-rheumatic drugs (DMARDs) or the standard SLE treatment will not be interrupted with the exception of systemic steroids (excluding minimal maintenance dose of one steroid) during the duration of the study. Follow up visits will take place at 6 weeks, 3 Months and 6 Months after the cell infusion. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 10 patients have been enrolled and treated in each group.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Rheumatoid Arthritis Sharp's Syndrome Other: Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs Other: Lipoaspiration Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Open- Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Autologous Adipose Stem Cell (Adult Human) to Subjects With Refractory Rheumatoid Arthritis, Relapsing Systemic Lupus Erythematosus or Sharp's Syndrome
Study Start Date : December 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: ADSC arm
Single intravenous administration of Stromal Vacsular Fraction (SVF) cells soinating Adipose Derived Stem Cells (ADSC) 6 week baseline data prior to the injection of ADSC will be collected. 6 week, 3 months and 6 months follow up data will be compared against baseline.
Other: Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs
Other Name: Tissue transplant

Other: Lipoaspiration

Primary Outcome Measures :
  1. Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) during a 6 month follow up period. [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Quality of Life Questionnaires for SLE/ RA [ Time Frame: 6 Months ]
    SLEQoL score

  2. Quality of Life Questionnaires for RA [ Time Frame: 6 Months ]
    DAS-28 score

  3. Blood Flow Cytometry for CD4+CD25+Foxp3+ regulatory T cells [ Time Frame: 6 Months ]
    CD4+CD25+Foxp3+ regulatory T cells,

  4. Blood Flow Cytometry for CD3+CD8-IL17A+TH17 cells [ Time Frame: 6 Months ]
    CD3+CD8-IL17A+TH17 cells

  5. Serum C- reactive protein (CRP) [ Time Frame: 6 Months ]
    C- reactive protein (CRP)

  6. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 6 Months ]
    Erythrocyte Sedimentation Rate (ESR)

  7. Serum Tumor Necrosis Factor- alpha (TNFa) [ Time Frame: 6 Months ]
    Tumor Necrosis Factor- alpha (TNFa)

  8. Serum Transforming Growth Factor- beta (TGFb) [ Time Frame: 6 Months ]
    Transforming Growth Factor- beta (TGFb)

  9. Serum Interleukin- 6 (IL-6) [ Time Frame: 6 Months ]
    Interleukin- 6 (IL-6)

  10. Serum Interleukin- 17 (IL-17) [ Time Frame: 6 Months ]
    Interleukin- 17 (IL-17)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and Females ≥18 years
  2. Cognitive competitiveness.
  3. Diagnosis of refractory RA (patient's poor response of 3 months of DMARDs determined and documented by a rheumatologist) ,diagnosis of relapsing SLE (more than 2 episodes in a year during optimal medical SLE therapy) or diagnosis of Sharp syndrome (Alarcon-Segovia's criteria: patients with U1 Ribonucleic protein (RNP) ≥ 1:1600, and three of the following: Swollen hands, Synovitis, Myositis, Raynauld's phenomenon, Acrosclerosis)
  4. Life expectancy greater than 8 months
  5. Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf
  6. Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits
  7. No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.
  8. Written informed consent

Exclusion Criteria:

  1. Currently on systemic steroids (if chronic steroid therapy cannot be stopped, the patient will qualify if he/she is on a minimum maintenance dose per SLE, RA or SS guidelines of only one systemic steroid and constituting a bioequivalent to normal endogenous levels of that hormone).
  2. Dementia.
  3. Presence of immune deficiency.
  4. Currently on NSAIDs, TNFa inhibitors, Calcium channel blockers or P2Y12 inhibitors
  5. Complicated type 2 diabetes mellitus (presence of diabetic foot, advanced kidney disease or retinopathy).
  6. History of cancer within the past 5 years.
  7. Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject
  8. Participation in another study with an investigational drug or device within 3 weeks prior to treatment
  9. History within the past year of drug or alcohol abuse.
  10. Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study.
  11. Inability to comply with the conditions of the protocol.
  12. Porphyria.
  13. Allergy to sodium citrate or any "caine" type of local anesthetic.
  14. Patient scheduled for hospice care.

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): NCT02741362

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United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
Sponsors and Collaborators
Arkansas Heart Hospital
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Principal Investigator: Gerardo Rodriguez, MD PhD Arkansas Heart Hospital
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Responsible Party: Arkansas Heart Hospital
ClinicalTrials.gov Identifier: NCT02741362    
Other Study ID Numbers: ICMS-2015-51
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Arkansas Heart Hospital:
Type III hypersensitivity autoimmune disease
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Mixed Connective Tissue Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases