Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

April 26, 2017 updated by: Royan Institute

Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mesenchymal stem cell receipients
Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.
Biological: Mesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Other Names:
  • stem cell transplantation
PLACEBO_COMPARATOR: Placebo
Placebo injection in the site of fracture in patients with tibia fracture.
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Mohsen Emaddedin, MD, Department or regenerative medicine of Royan Institute.
  • Principal Investigator: Aziz Ahmadi, MD, Scientific board of Iranian Orthopedic Association
  • Principal Investigator: Maedeh Ghorbani, MD, Department of Regenerative Medicine
  • Principal Investigator: Afshin Farhadi, MD, Scientific board of Iranian Orthopedic Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (ESTIMATE)

May 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Bone-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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