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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

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

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

Current Secondary Outcome Measures ^ICMJE

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.

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

Phase 1/Phase 2

Study Design ^ICMJE

Allocation:
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: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

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 ^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 and baseline (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 baseline. - 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

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:

Responsible Party

，

Study Sponsor ^ICMJE

Hope Biosciences

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

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

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