Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

NCT01206179 | Completed Phase 1 DMC

• 1 other identifier: Royan-Bone-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields). Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later surgeries required to augment the healing process and to accelerate the time to healing.

Conditions

Nonunion Fractures

Keywords

nonunion fracture bone formation pain relief

Outcome Measures

Primary Outcomes (1)

• Radiological progression of bone fusion

  callus formation in fracture zone

  3 months

Secondary Outcomes (2)

• Reduction of pain using VAS

  6 months

• Cost analysis based on length of hospital stay

  6 months

Study Arms (1)

non union

EXPERIMENTAL

Patients with nonunion fracture of long bones

Biological: cell injection

Interventions

cell injection BIOLOGICAL

Injection of mesenchymal cells in fractured zone

Also known as: Cell transplantation

non union

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders are eligible
• Nonunion or delayed union diagnosed with X-Ray examination.
• More than 4 cm distance to joint
• Provided written informed consent

You may not qualify if:

• Multiple major fracture or untreated major fracture
• Infected fracture
• HIV, hepatitis B or hepatitis C infection at the time of screening
• Pregnant or lactating women
• Diagnosis of cancer
• Active treatment with immunosuppressive drugs or anticoagulant agent
• Known allergic reaction to components of study treatment and/or study injection procedure

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (2)

• Emadedin M, Labibzadeh N, Fazeli R, Mohseni F, Hosseini SE, Moghadasali R, Mardpour S, Azimian V, Goodarzi A, Ghorbani Liastani M, Mirazimi Bafghi A, Baghaban Eslaminejad M, Aghdami N. Percutaneous Autologous Bone Marrow-Derived Mesenchymal Stromal Cell Implantation Is Safe for Reconstruction of Human Lower Limb Long Bone Atrophic Nonunion. Cell J. 2017 Apr-Jun;19(1):159-165. doi: 10.22074/cellj.2016.4866. Epub 2016 Dec 21.

  PMID: 28367426 DERIVED

• Labibzadeh N, Emadedin M, Fazeli R, Mohseni F, Hosseini SE, Moghadasali R, Mardpour S, Azimian V, Ghorbani Liastani M, Mirazimi Bafghi A, Baghaban Eslaminejad M, Aghdami N. Mesenchymal Stromal Cells Implantation in Combination with Platelet Lysate Product Is Safe for Reconstruction of Human Long Bone Nonunion. Cell J. 2016 Fall;18(3):302-309. doi: 10.22074/cellj.2016.4557. Epub 2016 Aug 24.

  PMID: 27602311 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

Carboxylesterase; Cell Transplantation

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Hamid Gourabi, PhD

  President of Royan Institute

  STUDY CHAIR

• Mohammad reza Baghban Eslami Nejad, PhD

  Sientific Board

  STUDY DIRECTOR

• Mohssen Emadeddin, MD

  Orthopadic Investigator

  PRINCIPAL INVESTIGATOR

• Nasser Aghdami, MD,PhD

  Head of Regenerative center

  PRINCIPAL INVESTIGATOR

• Ahmad Vosough, MD

  Radiologist investigator

  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 20, 2010
• First Posted: September 21, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 14, 2011

Record last verified: 2008-06

Locations

IR (1)