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Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Primary Purpose

Tibial Fracture

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mesenchymal stem cell injection
Placebo
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fracture focused on measuring Allogenic adipose derived mesenchymal stem cell tibial fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or uncontrolled diabetes or heart and lung disease
  • immune deficiency

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesenchymal stem cell receipients

Placebo

Arm Description

Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.

Placebo injection in the site of fracture in patients with tibia fracture.

Outcomes

Primary Outcome Measures

Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group

Secondary Outcome Measures

Full Information

First Posted
May 14, 2014
Last Updated
April 26, 2017
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02140528
Brief Title
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Official Title
Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.
Detailed Description
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) . To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fracture
Keywords
Allogenic adipose derived mesenchymal stem cell tibial fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell receipients
Arm Type
Experimental
Arm Description
Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo injection in the site of fracture in patients with tibia fracture.
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cell injection
Other Intervention Name(s)
stem cell transplantation
Intervention Description
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 or uncontrolled diabetes or heart and lung disease immune deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of regenerative medicine department &cell therapy center of Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emaddedin, MD
Organizational Affiliation
Department or regenerative medicine of Royan Institute.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aziz Ahmadi, MD
Organizational Affiliation
Scientific board of Iranian Orthopedic Association
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maedeh Ghorbani, MD
Organizational Affiliation
Department of Regenerative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Afshin Farhadi, MD
Organizational Affiliation
Scientific board of Iranian Orthopedic Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://Royaninstitute.org
Description
Related Info

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Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

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