Phase 2
Completed N=15
Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03691909 ↗Enrolled (actual)
15
Serious AEs
26.7%
Results posted
Mar 2022
Primary outcomePrimary: Total Number of Adverse Events and Serious Adverse Events — 27; 15; 8; 4 count of events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Adverse Events and Serious Adverse Events |
27; 15; 8; 4; 4; 0 | — |
| SECONDARY The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA |
1.15 | 0.743 |
| SECONDARY The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA |
4.60 | 0.714 |
| SECONDARY The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA |
6.00 | 0.183 |
| SECONDARY The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA |
34.5 | 0.775 |
| SECONDARY The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA. |
1.00; 1.00 | 0.0008 sig |
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.
Data sourced from ClinicalTrials.gov (NCT03691909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.