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Trial record 93 of 799 for:    Interventional Studies | mesenchymal

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

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ClinicalTrials.gov Identifier: NCT02646007
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.


Condition or disease Intervention/treatment Phase
Kienböck's Disease Biological: BM-MSC transplantation Phase 1

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 : Interventional
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BM-MSC
Bone marrow derived mesenchymal stromal/stem cells injection during decompressive surgery in patients with Kienböck's disease.
Biological: BM-MSC transplantation
Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.




Primary Outcome Measures :
  1. Pain [ Time Frame: 3months ]
    The pain reduction at least 3 months after BM-MSC transplantation cells in combination with bone decompression.

  2. Bone density [ Time Frame: 3 months ]
    The improvement of bone density at least 3months after BM-MSC transplantation in MRI.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646007


Contacts
Contact: Nasser Aghdami, MD,PhD (+98)23562000 ext 516 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)23562000 ext 414 leara91@gmail.com

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD    (+98)23562000 ext 516    nasser.aghdami@royaninstitute.org   
Contact: Leila Arab, MD    (+98)23562000 ext 414    Leara91@gmail.com   
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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.

Additional Information:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02646007     History of Changes
Other Study ID Numbers: Royan-Bone-014
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Royan Institute:
Autologous Cell therapy Kienböck's disease
bone marrow derived mesenchymal stromal/stem cell

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes