Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis (hUC-MSC-SLE)

CytoMed & Beike

Status and phase: Unknown; Phase 2

Conditions: Lupus Nephritis

Treatments: Biological: Human Umbilical Cord derived MSCs; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01539902

CT 11-03

Details and patient eligibility

About

The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.

Full description

Inclusion criteria:

1. Male or non-pregnant females age 16 to 65 years inclusive.
2. Written informed consent obtained from patient or parents/guardian.
3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.

Enrollment: 25 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or non-pregnant females age 16 to 65 years inclusive.
2. Written informed consent obtained from patient or parents/guardian.
3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score>8 or BILAG score A/B.
4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis

Exclusion criteria

Patients with any of the following are not eligible for enrollment into the study:

1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Serum creatinine more than 250 µmol/L.
5. White blood cell (WBC) count of less than 3.5 X 109/L.
6. Active peptic ulcer disease.
7. Active systemic infection.
8. History of alcohol or substance abuse.
9. History of malignancy within previous 5 years.
10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

25 participants in 2 patient groups, including a placebo group

Human Umbilical Cord derived MSCs

Experimental group

Treatment:

Biological: Human Umbilical Cord derived MSCs

Cyclophosphamide

Placebo Comparator group

Treatment:

Drug: Cyclophosphamide