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Completed

NCT Number: NCT02140528

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.

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Key information

Conditions

Tibial Fracture Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal Stem Cell Injection

Biological

Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .

Other names: stem cell transplantation

Placebo

Biological

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 16, 2014
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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