Distraction Osteogenesis in Limb-length Discrepancy With Mesenchymal Cell Transplantation

NCT01210950 | Completed Phase 1 DMC

• 1 other identifier: Royan-Bone-006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Leg Length Inequality

Keywords

distraction; osteogenesis; limb length discrepancy; callus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• improve life quality

  12 months

Study Arms (1)

cell and RPR recepients

EXPERIMENTAL

mesenchymal cells and plasma reach protein are injected to the callus center of short limb

Biological: cell and RPR injection

Interventions

cell and RPR injection BIOLOGICAL

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

Also known as: cell therapy

cell and RPR recepients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender
• patient with limb-length discrepancy
• Age:18-65

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Royan Institute

MeSH Terms

Conditions

Leg Length Inequality; Callosities

Interventions

Carboxylesterase; Reagins; Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Therapy; Therapeutics

Study Officials

• Hamid Gourabi, PhD

  President of Royan Institute

  STUDY CHAIR

• Mohammad reza Baghban Eslami Nejad, PhD

  Board scientific

  STUDY DIRECTOR

• Mohssen Emadeddin, MD

  Orthopadic Investigator

  PRINCIPAL INVESTIGATOR

• Nasser Aghdami, MD,PhD

  Head of Regenerative center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2008-04

Locations

IR (1)