Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01198080
First received: September 8, 2010
Last updated: August 27, 2013
Last verified: April 2009
  Purpose

Avascular necrosis is a disease where there is cellular death (necrosis) of bone components due to interruption of the blood supply. Without blood, the bone tissue dies and the bone collapses. If avascular necrosis involves the bones of a joint, it often leads to destruction of the joint articular surfaces. Avascular necrosis is especially common in the hip joint. A variety of methods are now used to treat avascular necrosis the most common being the total hip replacement, or THR.A new, more promising treatment is hip resurfacing or metal on metal (MOM) resurfacing.Another treatment is utilization of bone marrow derived stem cells.these stem cells can provide angiogenic factors and osteogenic cytokine to improve angiogenesis and bone formation.


Condition Intervention Phase
Osteonecrosis
Biological: CD133+ cells
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Marrow Derived CD133+ Stem Cells Transplantation in Femoral Head Osteonecrosis

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • safety of bone marrow derived CD133+ cells transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Evaluation safety of bone marrow CD133+ cells transplantation in patients with osteonecrosis of femoral head


Secondary Outcome Measures:
  • improve patient quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    evaluate the ability of bone marrow derived CD133+ cells to improve patient quality of life

  • decrease hip articular change [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    evaluate the ability of bone marrow derived CD133+ cells to decrease hip articular change

  • side effects [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Evaluate side effects of bone marrow derived CD133+ cells transplantation


Enrollment: 10
Study Start Date: August 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: femoral osteonecrosis patients
patientswith femoral head osteonecrosis
Biological: CD133+ cells
bone marrow derived CD133+ cells injection with core compression
Other Name: cell injection

Detailed Description:

A vascular necrosis of femoral head is a debilitating disease resulting from interruption of blood supply to the bone. This pathologic process results in the death of marrow and osteocytes and, in its final stage, femoral head collapse. The most widespread treatment in the early stage of this disease is core decompression. This surgical procedure involves drilling into the femoral neck through the necrotic area, which reduces pressure within the bone and allows more blood vessels to form. This study is designed to evaluate the clinical safety and efficacy of CD133+ enriched bone marrow infusion adjacent with core decompression in patients with a vascular necrosis of femoral head . Patients will undergo core decompression followed by CD133+cell infusion into the cored area. Clinical assessment includes a MRI, Harries Hip Score,SF36, Visual Analogue Scale(VAS), and the WOMAC osteoarthritis Index.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upenn (Steinberg) classification of osteonecrosis, inclusive of Stages IIB and IIC. Diagnosis will be based on magnetic resonance imaging (MRI).
  • Modified index of necrotic extent < 40
  • Idiopathic and non-idiopathic osteonecrosis.
  • No infection in affected bones at the time of surgery.
  • Patient competent to give informed consent.
  • Normal organ and marrow function defined as:

    • Leukocytes ≥ 3000/µL;
    • Absolute neutrophil count ≥ 1500/µL;
    • Platelets ≥ 140,000/µL;
    • Serum AST (SGOT)/ALT (SGPT) < 2.5 X institutional standard range;
    • Serum creatinine within normal limits, based on clinical laboratory normal range.
  • Female patients not pregnant or lactating.
  • Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior and 6 months after cell therapy and surgery.
  • Patients who have been treated with oral bisphosphonates are eligible for the trial if treatment was stopped at least 6 months prior to enrollment.

Exclusion Criteria:

  • Stages IA, IB, IC, IIA, IIIA or more severe femoral head osteonecrosis, primarily based on diagnosis by MRI.
  • Flattening of the femur head (UPenn Stage IV) or articular cartilage collapse at the time of core decompression surgery.
  • Septic arthritis; stress fracture, or non-osteonecrosis metabolic bone diseases (e.g., Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, fibrous dysplasia [monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
  • Any active bisphosphonate treatment or any history of intravenous (IV) treatment
  • HIV, syphilis, positive at time of screening.
  • Active hepatitis B or hepatitis C infection at the time of screening
  • Known allergies to protein products (horse or bovine serum, or porcine trypsin).
  • Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery.
  • received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
  • Immunodeficiency diseases.
  • Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
  • History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz [150 mL] of wine or 12 oz [360 mL] of beer or 1.5 oz [45 mL] of hard liquor) within 6 months of screening and/or history of illicit drug use.
  • MRI-incompatible internal devices (pacemakers, aneurysm clips, etc)
  • Body mass index (BMI) of 40 Kg/m2 or greater
  • Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2
  • Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
  • Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or anti-angiogenesis treatment
  • Traumatic osteonecrosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198080

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Principal Investigator: Ahmad Vosough, MD Board scientific
Principal Investigator: Nasser Aghdami, MD,PhD Head of regenerative medicine center
Study Director: Mohammad Reza Baghban Eslami, PhD Board Sientific
Principal Investigator: mohssen Emadeddin, MD Orthopedic Investigator
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01198080     History of Changes
Other Study ID Numbers: Royan-Bone-003
Study First Received: September 8, 2010
Last Updated: August 27, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Avascular osteonecrosis,CD133+,core decompression

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014