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A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Ex-Vivo Cultured Allogenic Mesenchymal Stem Cells For the Treatment of Extensive Chronic Graft Versus Host Disease

Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000536
Enrollment
Unknown
Registered
2009-09-28
Start date
2009-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive chronic graft versus host disease

Interventions

A:Glucocorticoids+CSA/FK506
B:Glucocorticoids+CSA/FK506+MSC

Sponsors

Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained from patient and donor; 2. Any patient who has undergone allogeneic stem cell transplantation with extensive chronic GVHD; 3. Have not received additional agent for cGVHD within 3 months; 4. Expected life is more than 90 days; 5. Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease; 6. Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.

Exclusion criteria

Exclusion criteria: 1. Invasive fungal disease; 2. Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease); 3. Patient is with a history of hypersensitivity to bovine products; 4. Relapsed malignancy.

Design outcomes

Primary

MeasureTime frame
Remission rate (CR and PR);Safety of MSC treatment;

Secondary

MeasureTime frame
Effect on OS, DFS and QOL;The total Response rate;

Countries

China

Contacts

Public ContactXin Du
miyadu@hotmail.com+86 020 83827812-62122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026