Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)

Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase Ⅰ/Ⅱ

Sponsoren

Hauptsponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Quelle The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Kurze Zusammenfassung

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

detaillierte Beschreibung

- To test a new approach using allogeneic derived mesenchymal stem cell based therapy (MSCT) to treat refractory primary Sjögren's Syndrome (pSS)

- To determine the disease-free survival in pSS patients treated with MSCT in terms of disease activity index, pSS serology and salivary gland function

- To assess adverse events of allogeneic MSC transplantation

- To assess the association of disease activity index, pSS serology levels, and saliva flow rate at baseline with disease-free survival

Gesamtstatus Unknown status
Anfangsdatum June 2009
Fertigstellungstermin December 2011
Primäres Abschlussdatum December 2010
Phase Phase 1/Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Sjögren's syndrome disease activity index Monthly
Sekundäres Ergebnis
Messen Zeitfenster
pSS Serology (ANA, dsDNA, SS-A, SS-B) Monthly
Improvement of salivary gland function (measured as stimulated saliva flow rate) Monthly
Einschreibung 20
Bedingung
Intervention

Interventionsart: Biological

Interventionsname: Allogeneic Mesenchymal Stem Cells (AlloMSC)

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

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- All patients fulfilled the international classification criteria (2002) for primary Sjögren's Syndrome, man or woman aged from 15 to 70 years old, Sjögren's Syndrome Disease Activity Index (SSDAI)≥8.

- Stimulated whole saliva flow rate less than 1~6ml/6min.

- Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.

- Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial and for 12 months following treatment. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.

Exclusion Criteria:

- End-stage renal failure.

- Severe cardiopulmonary compromise, or other system failure.

- Active, uncontrolled infections.

- Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.

Geschlecht: All

Mindestalter: 15 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Lingyun Sun, MD Principal Investigator the Affiliated Drum Tower Hospital of Nanjing University Medical School
Gesamtkontakt

Nachname: Lingyun Sun, MD

Telefon: +86-25-83105219

Email: [email protected]

Ort
Einrichtung: Status: the Affiliated Drum Tower Hospital of Nanjing University Medical School
Standort Länder

China

Überprüfungsdatum

August 2009

Verantwortliche Partei

Nenne den Titel: the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Organisation: the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov