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Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

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ClinicalTrials.gov Identifier: NCT02140528
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Tibial Fracture Biological: Mesenchymal stem cell injection Biological: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Actual Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: stem cell transplantation

Placebo Comparator: Placebo
Placebo injection in the site of fracture in patients with tibia fracture.
Biological: Placebo



Primary Outcome Measures :
  1. Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140528


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of regenerative medicine department &cell therapy center of Royan Institute
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

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02140528     History of Changes
Other Study ID Numbers: Royan-Bone-012
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Royan Institute:
Allogenic adipose derived mesenchymal stem cell tibial fracture

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries