Kienböck's Disease Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Royan Institute | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| Royan Institute |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain | The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression. | 3months | Yes |
| Primary | Bone density | The improvement of bone density at least 3months after BM-MSC transplantation in MRI. | 3 months | Yes |
| Secondary | 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. | 3 months | Yes |
| Secondary | Infection: Presence of any sign or symptoms of infection | presence of any sign or symptoms of infection in site of surgery during 1 week. | 1week | Yes |
| Secondary | 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. | 3months | Yes |