Clinical trial NCT02646007: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Kienböck's Disease
Keywords: Autologous Cell therapy Kienböck's disease
bone marrow derived mesenchymal stromal/stem cell
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain
timeFrame: 3months
measure: Bone density
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life evaluated by Visual Analogue Score (VAS)
timeFrame: 3 months
measure: Infection: Presence of any sign or symptoms of infection
timeFrame: 1week
measure: Cyst formation: Presence of any cyst or mass formation
timeFrame: 3months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of department of Regenerative Medicine & Cell therapy center, Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Tehran university of medical science, department of orthopedic surgery
name: Hamidreza Mehrpour, MD
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Mohsen Emadedin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Narges Labibzadeh, MD
role: PRINCIPAL_INVESTIGATOR
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