Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01210950
Other study ID # Royan-Bone-006
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05122533 - Reliability of Clinical Limb-length Measurements Methods
Terminated NCT03752814 - SYNOSTE Nitinail System Trial N/A
Completed NCT03966573 - Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints N/A
Withdrawn NCT00624299 - Botox Clinical Trial Phase 4
Recruiting NCT06156384 - Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Completed NCT01803243 - Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups N/A
Completed NCT01894100 - Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms N/A
Completed NCT04713397 - Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics
Completed NCT03048656 - The Postural Control in Individuals With the Structural Leg-length Discrepancy N/A
Completed NCT01187693 - The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy N/A

External Links