MedTrace Logo

Autologous BM-MSC Transplantation in Combination With Platelet Lysate (PL) for Nonunion Treatment

NCT02448849 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-10-30

No results posted yet for this study

Summary

Nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients.

Cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.

Percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with PL will be done in 30 patients with tibia nonunion. The other 30 patients as the control group will receive placebo. The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.

The Spss(v16) software will be used for data analysis.

Conditions

  • Bone Fracture

Interventions

BIOLOGICAL

Percutaneous injection

percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.

OTHER

Percutaneous injection

Percutaneous implantation of placebo in patients with nonunion fracture.

Sponsors & Collaborators

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Hamid Gourabi, PhD · Head of Royan Institute

  • Nasser Aghdami, MD,PhD · Head of Regenerative medicine department and cell therapy center of Royan Institute

  • Mohammad Razi, MD · Department of orthopedic surgery, Tehran university of medical science, Tehran, Iran

  • Mohsen Emadedin, MD · Cell therapy center of Royan Institute

  • Narges Labibzadeh, MD · Department of Regenerative Medicine and cell therapy center, Royan Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-04-30
Completion
2017-08-31

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02448849 on ClinicalTrials.gov