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Safety and Efficacy of Allogeneic Mesenchymal Stem cell Transplantation in Tibial Fractures (Closed Diaphyseal) clinical trial phase II

Protocol summary

Summary
Study object: Accelerating the tibial union and decreasing muscle weakness, joint pain and stiffness through injection of allogenic adipose derived mesenchymal stem cells. Study design: During a parallel randomized triple-blind clinical trial phase II, 40 patients with new closed tibial shaft fracture visited in Akhtar orthopedic clinics, randomly allocated to case and control groups. Setting and conduct: Placebo in the control group, and prepared allogeneic adipose-derived mesenchymal stem cells are injected in the case one, and then patients will be followed in determined times. Inclusion and exclusion criteria: Patients with 18 to 65 years old whose closed diaphyseal fracture of tibia have been proved via radiography, and are not addicted, pregnant or suffering from chronic diseases or immune deficiency, will be recruited in this study. Outcomes: Clinical and functional effects and probable adverse events following the stem cell injection will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201508061031N11
Registration date: 2017-03-15, 1395/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-15, 1395/12/25
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2014-11-09, 1393/08/18
Expected recruitment end date
2015-06-13, 1394/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy of Allogeneic Mesenchymal Stem cell Transplantation in Tibial Fractures (Closed Diaphyseal) clinical trial phase II
Public title
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age 18 to 65 years; The presence of tibial fracture based on X ray; Tibial fracture is limited to diaphysial. Exclusion Criteria: Addiction; Pregnancy; liver or kidney disease; uncontrolled diabetes; heart and lung disease; Immune deficiency.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

1

Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02140528
Registration date
2014-05-14, 1393/02/24

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, Resalat highway 45 meters
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
EC/92/1099

Health conditions studied

1

Description of health condition studied
Tibial Closed Diaphyseal Fractures
ICD-10 code
S82.2
ICD-10 code description
Fracture of shaft of tibia

Primary outcomes

1

Description
Union of tibia after transplantation of mesenchymal stem cell
Timepoint
Before 3 and 6 months after injection
Method of measurement
X-ray radiography, walking distance, and whole body weight bearing by fractured limb

Secondary outcomes

1

Description
Evaluation of adverse events such as infection and edema in the fracture site
Timepoint
Before 3 and 6 months after injection
Method of measurement
Physical examination

Intervention groups

1

Description
Intervention: Single dose injection of 20 millions of allogenic adipose-derived mesenchymal stem cells into the fracture site
Category
Treatment - Drugs

2

Description
Control: Single dose injection of 3 to 5 ml normal saline into the fracture site
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Cell Therapy Center
Full name of responsible person
Fateme Shams
Street address
number 9, Shaghayegh Alley, Banihashem Sq., 45 m Resalat Highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Shahedeh Karimi Torshizi
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Royan institute, Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
00
Fax
Email
karimi58shah@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Cell Therapy Center
Full name of responsible person
Nasser Aghdami
Position
M.D, Ph.D
Other areas of specialty/work
Street address
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
Researcher/M.D
Other areas of specialty/work
Street address
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
00
Fax
Email
hoda62_m@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
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