The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

NCT01788059 | Completed Phase 2 DMC

• 1 other identifier: 900939
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.

Conditions

Nonunion Fracture

Keywords

nonunion; mesenchymal stem cell; long bone

Outcome Measures

Primary Outcomes (1)

• clinical and radiological union at 1 month to 6 months

  patients receiving Mesenchymal Stem Cells that develop a partial or complete callus at 1, 2, 3, 4 ,5 and 6 months evaluate with standard X-rays

  6 months

Secondary Outcomes (2)

• •Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects.

  12 months

• Incidence of adverse events in patients (e.g infection , malignancy , ...) Adverse events will be continuously monitored

  12 months

Study Arms (1)

mesenchymal stem cell

EXPERIMENTAL

stem cells drived from iliac bone marrow with centrifuge and ficoll method then inject to non union site 2-3 ml with approximately 40 X 10E6 Mesenchymal Stem Cells (MSC) will be injected in the nonunion site of the bone fracture under fluoroscopic gide and general or spinal anesthesia as deemed appropriate by the anesthetist.

Other: injection the mesenchymal stem cell in non union site

Interventions

injection the mesenchymal stem cell in non union site OTHER

mesenchymal stem cell

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Every patient with non union in the site of long bone fracture
• Age more than 18 and under 60 years old
• Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
• No infection in site of surgery
• Be able and willing to participate in the study
• Written informed consent

You may not qualify if:

• Evidence of malignancy
• Pregnancy or breastfeeding
• Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing

Sponsors & Collaborators

• Emdadi Kamyab Hospital: lead

Study Sites (1)

Emdai Kamyab Hospital

Mashhad, Khorasan, Iran

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• mohammad taghi peivandi, MD

  Emdadi Kamyab Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: February 11, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

IR (1)