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

NCT01198080 | Completed Phase 1 DMC

• 1 other identifier: Royan-Bone-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteonecrosis

Keywords

Avascular osteonecrosis,CD133+,core decompression

Outcome Measures

Primary Outcomes (1)

• safety of bone marrow derived CD133+ cells transplantation

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

  6 months

Secondary Outcomes (3)

• improve patient quality of life

  12 months

• decrease hip articular change

  24 month

• side effects

  24 months

Study Arms (1)

femoral osteonecrosis patients

EXPERIMENTAL

patientswith femoral head osteonecrosis

Biological: CD133+ cells

Interventions

CD133+ cells BIOLOGICAL

bone marrow derived CD133+ cells injection with core compression

Also known as: cell injection

femoral osteonecrosis patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Osteonecrosis

Interventions

Carboxylesterase

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Ester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Ahmad Vosough, MD

  Board scientific

  PRINCIPAL INVESTIGATOR

• Nasser Aghdami, MD,PhD

  Head of regenerative medicine center

  PRINCIPAL INVESTIGATOR

• Mohammad Reza Baghban Eslami, PhD

  Board Sientific

  STUDY DIRECTOR

• mohssen Emadeddin, MD

  Orthopedic 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 8, 2010
• First Posted: September 9, 2010
• Study Start: August 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2009-04

Locations

IR (1)