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A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis (HB-adMSCs)

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: NCT03691909
Recruitment Status : Active, not recruiting
First Posted : October 2, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hope Biosciences

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE September 25, 2018
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 months ]
All subjects entered into the study and exposed to the IV infusion will have detailed information collected on adverse events, serious adverse events and secondary organ damage for the overall safety analysis.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03691909 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2018)
  • The effect of single inject of HB-adMSCs on TNF-a in patients with acute RA [ Time Frame: 12 months ]
    Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Tumor Necrosis factor (TNF-a) (pg/mL) measured during trial.
  • The effect of single inject of HB-adMSCs on IL-6 in patients with acute RA [ Time Frame: 12 months ]
    Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of interleukin 6 (IL-6) (pg/mL) during the trial
  • The effect of single inject of HB-adMSCs on CRP in patients with acute RA [ Time Frame: 12 months ]
    Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of C-reactive protein (CRP) (mg/mL) during the trial
  • The effect of single inject of HB-adMSCs on ESR in patients with acute RA [ Time Frame: 12 months ]
    Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of eritrosedimentation rate (ESR) (mL/hr) during the trial.
  • The effect of single inject of HB-adMSCs on joint count in patients with acute RA. [ Time Frame: 12 months ]
    Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Joint Count 66/68 (# joints - tender and swollen) during the trial.
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 A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis
Official Title  ICMJE A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis
Brief Summary Hope Biosciences is conducting a research study of an investigational product called autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for rheumatoid arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
Detailed Description This is a Phase 1/2a open label single dose study in subjects with active Rheumatoid Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. The second endpoint of this study is to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of autologous HB-adMSCs for up to 12-month post-infusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Hope Biosciences autologous mesenchymal stem cell therapy HB-adMSCs
a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
Study Arms  ICMJE Experimental: Treatment Arm
Single IV administration of autologous adipose-derived mesenchymal stem cells Baseline laboratory data will be collected prior to infusion; follow up data will be compared against baseline at 1, 3, 6 and 12 months. Joint Assessment 68 will be administered at 1, 3, 6 and 12 months.
Intervention: Biological: Hope Biosciences autologous mesenchymal stem cell therapy HB-adMSCs
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or female between the ages of 18 and 65
  • Patients have active RA as confirmed by the following criteria:

    • ≥ 6 swollen joints and ≥ 6 tender joints at screening (68-joint count)
    • Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at screening OR abnormal ESR defined as:
    • CRP > 4.9 mg/L or ESR > 10mm/hr for men, > 20mm/hr for women
  • Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening

Exclusion Criteria:

  • Inability to understand and provide signed informed consent

    • Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screening.
    • Currently diagnosed any malignant neoplasm. Any patient who was successfully treated for cancer and has been disease-free, with no recurrence, for at least 5 years, will be considered.
    • Uncontrolled systemic illness, including, but not limited to: hypertension (systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure or any laboratory abnormality that poses a safety risk to the subject such as:

      • Hemoglobin ≤8.5 g/dL
      • White blood cells (WBCs) ≤3,500/mm3 (3.5G/L)
      • Any other illness which, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study
    • Participation in another study with an investigational drug or device within 4 weeks prior to treatment or 5 half-lives of the investigational product used (whichever is longer).
    • Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening (excluding patients who are tested positive for HBsAb alone due to a hepatitis B vaccination).
    • Positive history of Treponema pallidum.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691909
Other Study ID Numbers  ICMJE HB-adMSCs for RA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hope Biosciences
Study Sponsor  ICMJE Hope Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Waller, MD Accurate Clinical Research
PRS Account Hope Biosciences
Verification Date April 2019

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