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NCT Number: NCT01210950

Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

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.

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Key information

Conditions

Leg Length Inequality Bone Diseases Bone Diseases, Developmental Callosities Keratosis Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cell and RPR injection

Biological

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

Other names: cell therapy

Primary outcomes

  1. effect of mesenchymal cell transplantation to decrease limb inequal

    Time frame: 6 months

    evaluate the effect of mesenchymal cells transplantation with plasma reach protein in limb lengthening and decrease limb inequal

Secondary outcomes

  1. improve life quality

    Time frame: 12 months

    mesenchymal cells transplantation improve patients life quality

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2010
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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