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

Primary Purpose

Osteonecrosis

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
CD133+ cells
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteonecrosis focused on measuring Avascular osteonecrosis,CD133+,core decompression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

femoral osteonecrosis patients

Arm Description

patientswith femoral head osteonecrosis

Outcomes

Primary Outcome Measures

safety of bone marrow derived CD133+ cells transplantation
Evaluation safety of bone marrow CD133+ cells transplantation in patients with osteonecrosis of femoral head

Secondary Outcome Measures

improve patient quality of life
evaluate the ability of bone marrow derived CD133+ cells to improve patient quality of life
decrease hip articular change
evaluate the ability of bone marrow derived CD133+ cells to decrease hip articular change
side effects
Evaluate side effects of bone marrow derived CD133+ cells transplantation

Full Information

First Posted
September 8, 2010
Last Updated
August 27, 2013
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01198080
Brief Title
Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head
Official Title
Bone Marrow Derived CD133+ Stem Cells Transplantation in Femoral Head Osteonecrosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis
Keywords
Avascular osteonecrosis,CD133+,core decompression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
femoral osteonecrosis patients
Arm Type
Experimental
Arm Description
patientswith femoral head osteonecrosis
Intervention Type
Biological
Intervention Name(s)
CD133+ cells
Other Intervention Name(s)
cell injection
Intervention Description
bone marrow derived CD133+ cells injection with core compression
Primary Outcome Measure Information:
Title
safety of bone marrow derived CD133+ cells transplantation
Description
Evaluation safety of bone marrow CD133+ cells transplantation in patients with osteonecrosis of femoral head
Time Frame
6 months
Secondary Outcome Measure Information:
Title
improve patient quality of life
Description
evaluate the ability of bone marrow derived CD133+ cells to improve patient quality of life
Time Frame
12 months
Title
decrease hip articular change
Description
evaluate the ability of bone marrow derived CD133+ cells to decrease hip articular change
Time Frame
24 month
Title
side effects
Description
Evaluate side effects of bone marrow derived CD133+ cells transplantation
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmad Vosough, MD
Organizational Affiliation
Board scientific
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of regenerative medicine center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Reza Baghban Eslami, PhD
Organizational Affiliation
Board Sientific
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohssen Emadeddin, MD
Organizational Affiliation
Orthopedic Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.royaninstitute.org
Description
Related Info

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

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