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
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 |
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.
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
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 |
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