Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

Nanjing University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Biological: human umbilical cord derived MSC transplantation for SLE

Study type

Interventional

Funder types

Other

Identifiers

NCT01741857

NJGLYY005

Details and patient eligibility

About

This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Full description

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;
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

Enrollment

40 estimated patients

Sex

All

Ages

15 to 60 years old

Volunteers

No Healthy Volunteers

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