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NCT02140528 Clinical Trial

Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Tibial Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02140528
Other study ID # Royan-Bone-012
Secondary ID
Status Completed
Phase Phase 2
First received May 14, 2014
Last updated April 26, 2017
Start date August 2013
Est. completion date April 2016

Study information
Verified date April 2017
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Mesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
• Placebo

Locations
Country Name City State
Iran, Islamic Republic of Royan Institute Tehran

Sponsors (1)
Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group 6 months
See also
  Status Clinical Trial Phase
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Completed NCT01017094 - Pin Site Infection Prevention for Open Tibial Fracture Phase 3
Completed NCT00038129 - SPRINT - Randomized Trial of Tibial Fracture Fixation N/A
Recruiting NCT01795287 - Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture N/A
Terminated NCT01300520 - The Development of a Surgical Localizing Aid Medical Device N/A
Active, not recruiting NCT05012449 - Transitional Ankle Fracture Management Using a New Joystick Technique N/A
Recruiting NCT04432389 - Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture Phase 2
Suspended NCT00365573 - Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity Phase 2
Completed NCT02820363 - Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures N/A
Completed NCT00264511 - Hyperbaric Oxygen in Lower Leg Trauma Phase 2/Phase 3
Completed NCT04028908 - Remodelling After Trampoline Fracture in Children
Active, not recruiting NCT03598530 - Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Not yet recruiting NCT01955577 - Vitamin D Supplement for Patients With Tibial Fracture Phase 1
Completed NCT00250302 - Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures Phase 1/Phase 2
Unknown status NCT02035917 - Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate N/A

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