Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

Leg Length Inequality Clinical Trial

Official title:

Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210950
• Other study ID #: Royan-Bone-006
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2010
• Last updated: April 24, 2014
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2008
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Limb-length discrepancy can be due to many causes. These are divided into three groups: congenital (from birth), developmental (from a childhood disease or injury that slows or damages the growth plates), and posttraumatic (from a fracture that leads to shortening of the bone ends). There are three ways to equalize the limb-length discrepancy: use a shoe lift, shorten the long leg, lengthen the short leg. Most patients do not like wearing a lift greater than 2 cm (3/4 in). For discrepancies greater than 2 cm but less than 5 cm (2 in), shortening of the long leg can be considered, especially for tall persons. For growing children, this can be easily accomplished with a small, minimally invasive, uncomplicated procedure called epiphysiodesis.The investigators aim to evaluate if injection of bone marrow derived mesenchymal stem cells can shorten the treatment period by acceleration of bone regeneration during distraction osteogenesis.

Description:

Distraction osteogenesis has been widely utilized to treat leg length discrepancy, deformity, nonunion, osteomyelitis, and bone loss. It has been found that most difficult conditions can be resolved with this method. In this study the aim is to observe if mesenchymal stem cell transplantation can enhance new bone formation during distraction osteogenesis.Patients undergo bone distraction , and about 2-3 weeks after distraction mesenchymal stem cell are injected at the callus site. In the case of large bone gap, mesenchymal stem cells are seeded on bone matrix and then placed in the bone gap. Each patient is assessed at interval time of 1 month for 6 months post surgery by X-Ray and at month 6 post surgery by computed tomography(CT) scans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• both gender

• patient with limb-length discrepancy

• Age:18-65

Exclusion Criteria:

• Diagnosis of cancer,DM,CNS disorder,thyroid disease or respiratory disease

• Known allergic reaction to components of study treatment and/or study injection procedure

• Patients infected with hepatitis B,C or HIV

• pregnancy

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Length Inequality

Intervention

Biological:
• cell and RPR injection
mesenchymal cells and Plasma reach Protein are injected to the callus center

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	effect of mesenchymal cell transplantation to decrease limb inequal	evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal	6 months	Yes
Secondary	improve life quality	mesenchymal cells transplantation improve patients life quality	12 months	Yes

External Links

•   Royan Institute