- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646007
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease
Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation for Human Avascular Necrosis of the Lunate Bone of the Wrist (Kienbock's Disease)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Leila Arab, MD
- Phone Number: 414 (+98)23562000
- Email: Leara91@gmail.com
Study Contact Backup
- Name: Nasser Aghdami, MD,PhD
- Phone Number: 516 (+98)23562000
- Email: nasser.aghdami@royaninstitute.org
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Royan Institute
-
Contact:
- Leila Arab, MD
- Phone Number: 414 (+98)23562000
- Email: Leara91@gmail.com
-
Contact:
- Nasser Aghdami, MD,PhD
- Phone Number: 516 (+98)23562000
- Email: nasser.aghdami@royaninstitute.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BM-MSC
Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.
|
Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 3months
|
The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.
|
3months
|
Bone density
Time Frame: 3 months
|
The improvement of bone density at least 3months after BM-MSC transplantation in MRI.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life evaluated by Visual Analogue Score (VAS)
Time Frame: 3 months
|
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.
|
3 months
|
Infection: Presence of any sign or symptoms of infection
Time Frame: 1week
|
presence of any sign or symptoms of infection in site of surgery during 1 week.
|
1week
|
Cyst formation: Presence of any cyst or mass formation
Time Frame: 3months
|
presence of any cyst or mass formation at least 3 months after BM-MSC transplantation with surgery.
|
3months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nasser Aghdami, MD,PhD, Head of department of Regenerative Medicine & Cell therapy center, Royan Institute
- Study Director: Hamidreza Mehrpour, MD, Tehran university of medical science, department of orthopedic surgery
- Principal Investigator: Mohsen Emadedin, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
- Principal Investigator: Narges Labibzadeh, MD, Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-Bone-014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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