Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)

Conditions

Mesenchymal Stem Cells, Systemic Sclerosis

Keywords

Systemic sclerosis, Mesenchymal Stem Cells, Transplantation

Brief summary

This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant to multiple standard treatments. The underlying hypothesis is that the SSc condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Detailed description

* To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory SSc * To determine the disease-free survival in SSc patients treated with MSCT * To assess adverse events of allogeneic MSC transplantation * To assess the association of remission for organ function, clinical score and SSc serology levels at baseline with disease-free survival

Alip M, Wang D, Zhao S, Li S, Zhang D, Duan X, Wang S, Hua B, Wang H, Zhang H, Feng X, Sun L.

2024-01-1110 citations

10.1007/s10067-024-06865-z

Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study

Jun Liang, Huayong Zhang, Wei Kong, Wei Deng, Dandan Wang et al. (10 authors)

Stem Cell Research & Therapy2018-11-14101 citations

10.1186/s13287-018-1053-4

Sustained benefit from combined plasmapheresis and allogeneic mesenchymal stem cells transplantation therapy in systemic sclerosis

Huayong Zhang, Jun Liang, Xiaojun Tang, Dandan Wang, Xuebing Feng et al. (9 authors)

Arthritis Research & Therapy2017-07-1950 citations

10.1186/s13075-017-1373-2

Interventions

BIOLOGICALAllogeneic Mesenchymal Stem Cells (AlloMSC)

Allogeneic mesenchymal stem cells will be infused intravenously (single dose, 10\^6 cells/kg body weight).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* All patients fulfilled the American College of Rheumatology (former American Rheumatism Association - ARA) for SSc * Rapidly progressive disease \<2 years duration with a modified Rodnan skin score(mRSS) above 20, plus ESR \>25 mm/first h and/or Hb \<11 g/dL, not explained by other causes than active SSc * lung involvement: with a vital capacity (VC) or DLCO below 70% predicted, or a mean pulmonary artery pressure (PAP) above 40 mmHg (measured by echocardiography) * digestive tract involvement: with serum albumin ,25 g/L or weight loss exceeding 10% body weight in the preceding year * kidney involvement: with 24-h urinary protein above 0.5 g or serum creatinine above 120 mmol/L

Exclusion criteria

* Uncontrolled arrhythmia, echocardiographic left ventricular ejection fraction (LVEF) \<50% or mean PAP \>50 mmHg, DLCO\<45% of predicted * Creatinine clearance \<20 ml/min * Platelets\<80 000/mm3, haemorrhagic cystitis * (4) HIV or HTLV1 seropositivity, malignancy, pregnancy, a cardiac or vascular prosthesis, and no vascular access

Design outcomes

Primary

Measure	Time frame
mRSS score,HRQOL score, SF-36 score for SSc patients	monthly

Secondary

Measure	Time frame
Remission for organ function, VC, DLCO, PAP, serum albumin, serum creatitin, weight loss, 24h proteinuria	every three month
SSc Serology(ATA,ACA,ANA,anti-ssDNA,anti-dsDNA,IgM,IgG,and IgA,complement C3 and C4	every three month
Change of peripheral blood B and T cells	every three month

Countries

China

Contacts

Primary ContactLingyun Sun, MD

lingyunsun2001@yahoo.com.cn+86-25-83105219

Outcome results

None listed