Back to resultsAutologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
Primary Purpose
Kienböck's Disease
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
BM-MSC transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Kienböck's Disease focused on measuring Autologous Cell therapy Kienböck's disease, bone marrow derived mesenchymal stromal/stem cell
Eligibility Criteria
Inclusion Criteria:
- Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
- Both genders
- Visual Analogue Scale of 4 or higher
- Hematological and biochemical analysis with no significant alterations that contraindicates intervention
- The patient is able to understand the nature of the study
- Informed written consent of the patient
Exclusion Criteria:
- Age over 65 or under 18 or legally dependent
- Infection signs or positive serology for HIV, hepatitis and syphilis
- Allergy to gentamicin, or to bovine, cattle or horse serum
- Pregnancy or lactating
- Pregnancy or breast-feeding
- Neoplasia
- Immunosuppression
- Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
- Other conditions that may, according to medical criteria, discourage participation in the study
Sites / Locations
- Royan InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BM-MSC
Arm Description
Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.
Outcomes
Primary Outcome Measures
Pain
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Bone density
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
Secondary Outcome Measures
Quality of life evaluated by Visual Analogue Score (VAS)
Improvement of quality of life inpatients after at least 3months of BM-MSC transplantation that is evaluated by Visual Analogue Score (VAS). The patients depends on their severity of the pain during daily activity choose a score between 1-10. The score will be saved in score sheets.
Infection: Presence of any sign or symptoms of infection
presence of any sign or symptoms of infection in site of surgery during 1 week.
Cyst formation: Presence of any cyst or mass formation
presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02646007
Brief Title
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
Official Title
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
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
Kienböck's disease is characterized by avascular necrosis of the lunate wrist bone, which is usually progressive without treatment.
Cell therapy is useful in treatment of degenerated bone and mesenchymal stromal/stem cells are the best candidates for this kind of treatment.
This study examined lunate core decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal cells for Its treatment potential.
Bone decompression in combination with implantation of autologous bone marrow derived mesenchymal stromal/stem cell will be done in 30 patients with Kienböck disease.
The patients will be followed at 2weeks, 3months, 6m and 12 months after implantation.
The Spss(v16) software will be used for data analysis.
Detailed Description
Kienböck's disease is characterized by avascular necrosis of the lunate wrist There is probably no single cause of avascular necrosis of the lunate. Its origin may involve multiple factors, such as the blood supply (arteries), the blood drainage (veins), and skeletal variations.
Current treatments are: at the early phase only observation. In the more advanced phases surgical techniques such as bone decompression.
A potential therapeutic strategy would be cell therapy, A source of such cells with a regenerative potential could be mesenchymal stem cells (MSCs).
The investigators will evaluate safety and efficacy of implantation of autologous BM-MSC (bone marrow-derived mesenchymal stromal cell) in 30 patients with Kienböck's disease in combination with bone decompression surgery. These patients will be followed up and data will be analyzed with spss(v16).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kienböck's Disease
Keywords
Autologous Cell therapy Kienböck's disease, bone marrow derived mesenchymal stromal/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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BM-MSC
Arm Type
Experimental
Arm Description
Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.
Intervention Type
Biological
Intervention Name(s)
BM-MSC transplantation
Intervention Description
Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.
Primary Outcome Measure Information:
Title
Pain
Description
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
Time Frame
3months
Title
Bone density
Description
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life evaluated by Visual Analogue Score (VAS)
Description
Improvement of quality of life inpatients after at least 3months of BM-MSC transplantation that is evaluated by Visual Analogue Score (VAS). The patients depends on their severity of the pain during daily activity choose a score between 1-10. The score will be saved in score sheets.
Time Frame
3 months
Title
Infection: Presence of any sign or symptoms of infection
Description
presence of any sign or symptoms of infection in site of surgery during 1 week.
Time Frame
1week
Title
Cyst formation: Presence of any cyst or mass formation
Description
presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
Time Frame
3months
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:
Kienböck's disease without response to conservative treatment (physical and medical) for over 6 months
Both genders
Visual Analogue Scale of 4 or higher
Hematological and biochemical analysis with no significant alterations that contraindicates intervention
The patient is able to understand the nature of the study
Informed written consent of the patient
Exclusion Criteria:
Age over 65 or under 18 or legally dependent
Infection signs or positive serology for HIV, hepatitis and syphilis
Allergy to gentamicin, or to bovine, cattle or horse serum
Pregnancy or lactating
Pregnancy or breast-feeding
Neoplasia
Immunosuppression
Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
Other conditions that may, according to medical criteria, discourage participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
leara91@gmail.com
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 department of Regenerative Medicine & Cell therapy center, Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hamidreza Mehrpour, MD
Organizational Affiliation
Tehran university of medical science, department of orthopedic surgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohsen Emadedin, MD
Organizational Affiliation
Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narges Labibzadeh, MD
Organizational Affiliation
Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Phone
(+98)23562000
Ext
516
Email
nasser.aghdami@royaninstitute.org
First Name & Middle Initial & Last Name & Degree
Leila Arab, MD
Phone
(+98)23562000
Ext
414
Email
Leara91@gmail.com
12. IPD Sharing Statement
Links:
URL
http://royaninstitute.org
Description
Related Info
Learn more about this trial
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
We'll reach out to this number within 24 hrs