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

July 18, 2016 updated by: Royan Institute

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

Unknown

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Biological: BM-MSC transplantation
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

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

January 3, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

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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