Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01539902
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
2012-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Sponsor:
CytoMed & Beike
Organization:
Study Overview
Official Title:
A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Status:
UNKNOWN
Status Verified Date:
2012-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
hUC-MSC-SLE
Brief Summary:
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: