Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Primary Purpose
Hip Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
stem cell injection
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring osteoarthritis, hip joint, mesenchymal stem cell
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis diagnosed by MRI
- End stage osteoarthritis candidate for total hip replacement
Exclusion Criteria:
- Pregnancy or lactating
- Positive tests for HIV, HCV, HBV
- Active neurologic disorder
- End organ damage
- Uncontrolled endocrine disorder
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hip osteoarthritis
Arm Description
The patients with hip joint osteoarthritis who underwent cell injection
Outcomes
Primary Outcome Measures
swelling of hip joint
Evaluatin the swelling of hip joint by physical examination after intra articular injection.
deterioration of joint function
Evaluation deterioration of joint function by physical examination after intra articular cell injection.
skin allergic reaction
Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Respiratory reaction
Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
Secondary Outcome Measures
Quantitative changes in pain intensity
Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
physical function improvement
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
subchondral bone edema
Evaluation the subchondral bone edema by MRI
cartilage thickness
measuring the cartilage thickness after cell transplantation by MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01499056
Brief Title
Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
Official Title
Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (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
Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis
Detailed Description
This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
osteoarthritis, hip joint, mesenchymal stem cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hip osteoarthritis
Arm Type
Experimental
Arm Description
The patients with hip joint osteoarthritis who underwent cell injection
Intervention Type
Biological
Intervention Name(s)
stem cell injection
Intervention Description
intra articular inection of mesenchymal stem cell
Primary Outcome Measure Information:
Title
swelling of hip joint
Description
Evaluatin the swelling of hip joint by physical examination after intra articular injection.
Time Frame
2 months
Title
deterioration of joint function
Description
Evaluation deterioration of joint function by physical examination after intra articular cell injection.
Time Frame
2 months
Title
skin allergic reaction
Description
Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Time Frame
1 week
Title
Respiratory reaction
Description
Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular cell injection.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Quantitative changes in pain intensity
Description
Evaluation Quantitative changes in pain intensity measured by Visual Analogue Scale after intra articular cell injection 2 months after cell transplantation in compare with base line (before injection)
Time Frame
2 months
Title
physical function improvement
Description
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index and Harris Hip Score.
Time Frame
2 months
Title
subchondral bone edema
Description
Evaluation the subchondral bone edema by MRI
Time Frame
2 months
Title
cartilage thickness
Description
measuring the cartilage thickness after cell transplantation by MRI
Time Frame
2 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:
Osteoarthritis diagnosed by MRI
End stage osteoarthritis candidate for total hip replacement
Exclusion Criteria:
Pregnancy or lactating
Positive tests for HIV, HCV, HBV
Active neurologic disorder
End organ damage
Uncontrolled endocrine disorder
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
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Royan Cell therapy Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emadeddin, MD
Organizational Affiliation
scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26058927
Citation
Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44.
Results Reference
derived
Learn more about this trial
Mesenchymal Stem Cell Transplantation in Osteoarthritis of Hip Joint
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