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Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01210950
Enrollment
6
Registered
2010-09-29
Start date
2009-09-30
Completion date
2013-12-31
Last updated
2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg Length Inequality

Keywords

distraction, osteogenesis, limb length discrepancy, callus

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.

Interventions

BIOLOGICALcell and RPR injection

mesenchymal cells and Plasma reach Protein are injected to the callus center

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effect of mesenchymal cell transplantation to decrease limb inequal6 monthsevaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal

Secondary

MeasureTime frameDescription
improve life quality12 monthsmesenchymal cells transplantation improve patients life quality

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026