Protocol summary

Summary
1- Objectives, Investigation on adult human mesenchymal stem cell transplantation on treatment of steroid-refractory acute graft-versus-host disease 2-Design, the study is designed as a phase 1-2, parallel, open-label, single-centric randomized clinical trial. In the beginning, among patients with acute graft-versus-host disease who eligible for inclusion criteria for cell therapy, ten patients as recipients and ten patients as control will be selected. 3- Setting and conduct, All stages of the project explain for each patients as recipient and healthy volunteers as donor, then if they want to enter the project inform consent would be obtained. Then, mesenchymal stem cells (MSCs) obtained via donors bone marrow aspiration would be cultured. After propagation of the cells, each patient will receive MSCs intravenously. Patients will be examined and visited by medical team on 1st, 4th, 7th, 14th, 21th, 28th days and six months after cell therapy and clinical and para-clinical indexes of patients will be assessed. 4- Participants including major eligibility criteria, steroid-refractory acute graft-versus-host disease with grade II to IV. 5- Intervention, Each patient will receive 1 million MSCs /kg by IV injection. 6- Main outcome measures (variables), Include assessing the efficacy of treatment by graft-versus-host disease clinical grading, acute and late onset side effects of mesenchymal stem cell therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014072618603N1
Registration date: 2015-10-26, 1394/08/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-10-26, 1394/08/04
Registrant information
Name
Fatemeh Amirmoezi
Name of organization / entity
Hematology research center/SUMS
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1563
Email address
amirmoezif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciencecs
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adult Human Mesenchymal Stem Cells for the treatment of Steroid-Refractory Acute Graft-versus-Host Disease
Public title
Adult Human Mesenchymal Stem Cells for the treatment of Steroid-Refractory Acute Graft-versus-Host Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recipients of allogeneic hematopoietic stem cell transplantation; patients with refractory acute graft versus host disease; subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion criteria: any abnormality in a vital sign (heart rate, respiratory rate, or blood pressure); patients with any conditions not suitable for the trial (investigators' decision)
Age
From 2 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor, Vice chancellery for research affairs, Shiraz University of Medical Sciences, Zand avenue, Shiaz, Iran
City
Shiraz
Postal code
Approval date
2015-09-05, 1394/06/14
Ethics committee reference number
IR.SUMS.REC.1394.97

Health conditions studied

1

Description of health condition studied
Graft-versus-host reaction or disease
ICD-10 code
T86.0
ICD-10 code description
Graft-versus-host reaction or disease

Primary outcomes

1

Description
The efficacy of treatment for refractory acute graft versus host disease
Timepoint
1, 4, 7, 14, 21, 28 days and 6 months after end of treatment
Method of measurement
The response criteria include complete response, part response, stable disease and progressive disease. complete response: acute graft versus host disease symptoms and signs disappear; part response: acute graft versus host disease symptoms and signs improve; stable disease: acute graft versus host disease symptoms and signs remain (without improvement or deterioration); progressive disease: acute graft versus host disease symptoms and signs deteriorate

Secondary outcomes

1

Description
Acute toxic side effects of mesenchymal stem cells treatment
Timepoint
1, 4, 7, 14, 21, 28 days after end of the treatment
Method of measurement
To asses acute toxicity principally involves the heart, liver and kidney and possible infections by clinical presentation and paraclinical evaluations

2

Description
Late toxic side effects of mesenchymal stem cells treatment
Timepoint
6 months after end of the treatment
Method of measurement
To asses late toxic side effects involves principally the development of secondary tumors, relapse of the primary disease and chronic graft versus host disease during 6 months of study by clinical presentation and paraclinical evaluations.

Intervention groups

1

Description
Intervention group: Patients who receive standard of care plus intravenous injection of 1 ± 0.5 × 106 cells/ kg recipient body weight of allogenic adult human mesenchymal stem cell
Category
Treatment - Other

2

Description
Control group: Patients who just receive standard of care include steroid therapy such as methylprednisolone 2 mg/kg daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital, Shiaz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Dr. Reza Vojdani
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research, Shiaz Univeisity of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th floor, Shiraz University of Medical Sciences, Zand avenue, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Shiaz Univeisity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Institute of Hematology -Oncology, Nemazee Hospital, Shiraz, Iran
Full name of responsible person
Dr. Reza Vojdani
Position
Assistant professor
Other areas of specialty/work
Street address
Nemazee hospital, shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1563
Fax
Email
vojdanir@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Hematology -Oncology, Nemazee Hospital, Shiraz, Iran
Full name of responsible person
Dr. Reza Vojdani
Position
Assistant professor
Other areas of specialty/work
Street address
52, West Hedayat street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3234 0767
Fax
Email
vojdanir@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hematology research center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Amirmoezi
Position
general physicion
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
00
Fax
Email
amirmoezif@sums.ac.ir; f_amirmoezi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...