Katy, Texas 77084


Purpose:

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.


Study summary:

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.


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 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.


NCT ID:

NCT03691909


Primary Contact:

Sherry Diers, RN
Phone: (832)975-8840
Email: Sherry@hope.bio


Backup Contact:

N/A


Location Contact:

Katy, Texas 77084
United States

Emily Birdshead
Email: ebirdshead@accurateclinicalresearch.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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