Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT01741857 |
Recruitment Status : Unknown
Verified October 2012 by Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was: Recruiting
First Posted : December 5, 2012
Last Update Posted : November 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Biological: human umbilical cord derived MSC transplantation for SLE | Phase 1 Phase 2 |
Inclusion Criteria:
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
- Lupus nephritis with 24h urine protein≥1g;
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Refractory disease as determined by failure of the following regimens:
Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 months following treatment
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II: Umbilical Cord Derived Mesenchymal Stem Cells Transplantation For Active And Refractory Systemic Lupus Erythematosus |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: human umbilical cord derived MSC
human umbilical cord derived MSC transplantation for SLE
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Biological: human umbilical cord derived MSC transplantation for SLE
Other Name: Allogenic MSC derived from umbilical cord |
- British Isles Lupus Assessment Group score (BILAG) [ Time Frame: up to 12 months ]
- Lupus serology (Alb, ANA, dsDNA, C3, C4) [ Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation ]
- Renal function (GFR, Blood Urea Nitrogen, urinalysis) [ Time Frame: pre-MSC transplantation, 1, 3, 6 and 12 months post MSC transplantation (for GFR assessed at baseline and 12 months after MSCT) ]

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Ages Eligible for Study: | 15 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 years old, SLEDAI≥8;
- Lupus nephritis with 24h urine protein≥1g;
- Refractory disease as determined by failure of the following regimens:
Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 months following treatment
Exclusion Criteria:
- Abnormal liver function (ALT higher than 3 times the normal value);
- End-stage renal failure;
- Severe heart and pulmonary failure, or other important organs damage;
- Uncontrolled infections
- Pregnant or breast feeding women, male or female who intended to recent pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741857
China, Jiangsu | |
The Affiliated Drum Tower Hospital of Nanjing University Medical School | Recruiting |
Nanjing, Jiangsu, China, 210008 | |
Contact: Sun +86-25-83105209 |
Principal Investigator: | Lingyun Sun, MD, PhD | the Affiliated Drum Tower Hospital of Nanjing University Medical School |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lingyun Sun, Department of Rheumatology and Immunology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
ClinicalTrials.gov Identifier: | NCT01741857 |
Other Study ID Numbers: |
NJGLYY005 |
First Posted: | December 5, 2012 Key Record Dates |
Last Update Posted: | November 5, 2013 |
Last Verified: | October 2012 |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |