Hospital Ampang
Ampang, Selangor, 68000, Malaysia
NCT Number: NCT03847844
Background: Graft-versus-host disease (GVHD) is a devastating complication following allogeneic hematopoietic stem cell transplantation (HSCT) mediated by stimulation of antigen presenting cells (APCs) which leads to donor T-lymphocytes activation and target tissue destruction, particularly affecting the skin, gastrointestinal tract, and liver in acute setting. In recent years, researchers have discovered that the application of mesenchymal stromal cells (MSCs) as salvage treatment among steroid refractory GVHD patients improves outcomes without long-term risk association. On the other hand, the use of MSCs concurrently with steroids as front-line treatment for acute GVHD has yet to be researched on. The investigators hypothesize that this approach, as the MSCs will be administered at earlier stage of the disease, will increase survival rate and reduce mortality among aGVHD patients.
Objective: In this study, the investigators aim to determine the efficacy and safety of allogeneic infusion of Cytopeutics® umbilical cord-derived mesenchymal stromal cells (Cyto-MSC) in combination of standard corticosteroid therapy as front-line approach for treatment of grade II-IV acute GVHD patients.
Study design: This is a phase I/II clinical study involving patients who underwent an allogeneic HSCT for malignant or non malignant haematological disorders and developed grade II-IV acute GVHD. A total of 40 eligible patients will be recruited in this study.
For Phase I open labelled study, 5 eligible patients will be recruited to receive Cyto-MSC (5 million UC-MSCs per kg bodyweight) and standard treatment. Meanwhile, for Phase II double blinded placebo controlled study, another 35 eligible patients will be recruited and randomized into 2 study groups where 15 patients will be assigned into Group A to receive Cyto-MSC (5 million UCMSCs per kg bodyweight) and standard treatment, meanwhile another 20 patients will be assigned into Group B to receive Placebo and standard treatment.
Cyto-MSC or Placebo will be administered at Day 1 and Day 4. Another infusion of Cyto-MSC or Placebo will be given at Day 7 if the patient shows no or partial response based on GvHD grading criteria. All patients will be assessed up until 6 months follow-up which include medical history, clinical and physical evaluations, pathology investigations, biomarkers and immune cell subsets analysis, as well as quality of life questionnaires.
Looking for future studies?
Notify Me16 year and older
All sexes
Interventional
Phase 1 / Phase 2
Ampang, Selangor, 68000, Malaysia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Umbilical cord derived mesenchymal stem cell
Other names: Cyto-MSC
Normal saline
Time frame: 28 days
Time frame: 28 days
Time frame: 14 days
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 3 months
Time frame: 90 days
Time frame: 3 months
Time frame: 3 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
The final score ranges from 0 (better outcome) to 126 (worse outcome)
Time frame: 6 months
The final score ranges from 0 (better outcome) to 164 (worse outcome)
Time frame: 6 months
The final score ranges from 0 (better outcome) to 92 (worse outcome)
Time frame: 6 months
The final score ranges from 0 (better outcome) to 100 (worse outcome)
Cytopeutics Sdn. Bhd.
Industry
Cytopeutics® Umbilical Cord Mesenchymal Stem Cells (Cyto-MSC) for Patients With Grade II -IV Acute Graft-Versus-Host Disease: A Phase I/II Clinical Study
Acronym: GVHD Cyto-MSC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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