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Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis

NCT03691909

CompletedPhase 1, Phase 2

Sponsor: Hope Biosciences LLC

Conditions: Rheumatoid Arthritis

Interventions: HB-adMSCs

Countries: United States

Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (3.5 G/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.

Locations (1)

Pasadena, Texas, United States