Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Royan Institute40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tibial Fracture

Interventions

Mesenchymal stem cell injectionBIOLOGICAL

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

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Royan Institute

Tehran, Iran

Outcomes

Primary Outcomes

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

Time frame: 6 months

Data from ClinicalTrials.gov

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