Clinical trial NCT03691909: Phase 1/2a Clinical Trial to Assess the Safety of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: arthritis
stem cells
MSCs
adipose MSCs
Lead sponsor: Hope Biosciences
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
Primary purpose: TREATMENT

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Total Number of Adverse Events and Serious Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA
timeFrame: 12 months
measure: The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA
timeFrame: 12 months
measure: The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA
timeFrame: 12 months
measure: The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA
timeFrame: 12 months
measure: The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.
timeFrame: 12 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Accurate Clinical Research
state: Texas
Study officials:
affiliation: Accurate Clinical Research
name: Philip Waller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vij R, Stebbings KA, Kim H, Park H, Chang D. Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial. Stem Cell Res Ther. 2022 Mar 3;13(1):88. doi: 10.1186/s13287-022-02763-w.