Clinical trial NCT01210950: Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation
Official title: Autologous Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Distraction Osteogenesis in Patients With Limb-length Discrepancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leg Length Inequality
Keywords: distraction
osteogenesis
limb length discrepancy
callus
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-09-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: effect of mesenchymal cell transplantation to decrease limb inequal
timeFrame: 6 months
Secondary outcomes:
measure: improve life quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: President of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Board scientific
name: Mohammad reza Baghban Eslami Nejad, PhD
role: STUDY_DIRECTOR
affiliation: Orthopadic Investigator
name: Mohssen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Regenerative center
name: Nasser Aghdami, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: