Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation(BM-MSC) for Kienbock's Disease

Royan Institute

Status and phase: Unknown; Phase 1

Conditions: Kienböck's Disease

Treatments: Biological: BM-MSC transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02646007

Royan-Bone-014

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

BM-MSC

Experimental group

Description:

Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.

Treatment:

Biological: BM-MSC transplantation