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)

• ClinicalTrials.gov Identifier: NCT03691909
• Recruitment Status: Active, not recruiting
• First Posted: October 2, 2018
• Last Update Posted: August 26, 2019
• Sponsor: Hope Biosciences
• Information provided by (Responsible Party): Hope Biosciences

Tracking Information

• First Submitted Date: September 27, 2018
• First Posted Date: October 2, 2018
• Last Update Posted Date: August 26, 2019
• Actual Study Start Date: September 25, 2018
• Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03691909 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 12, 2019)

• 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 erithrosedimentation 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 (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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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: Rheumatoid Arthritis

Intervention

Drug: HB-adMSC

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Study Arms

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: Drug: HB-adMSC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 28, 2018): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2020
• Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03691909
• Other Study ID Numbers: Rheumatoid Arthritis
• 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

• Plan to Share IPD: No

• Responsible Party: Hope Biosciences
• Study Sponsor: Hope Biosciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Philip Waller, MD; Accurate Clinical Research

• PRS Account: Hope Biosciences
• Verification Date: August 2019