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Allogenic Mesenchymal Stem Cell for Bone Defect or Non Union Fracture (AMSC)

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ClinicalTrials.gov Identifier: NCT02307435
Recruitment Status : Unknown
Verified December 2014 by Ismail Hadisoebroto Dilogo, Indonesia University.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University

Brief Summary:

Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long bone defect, the aspiration process through iliac crest is invasive and painful.

Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical cord is a "waste product" that proven to contain enormous MSC. Furthermore adipose and umbilical cord as an allogenic source is more abundant in number compares to autogenic bone marrow. This enormous source need and adequate preservation technique before applied to the patient. According to that, researchers want to explore the potency of MSC from bone marrow, umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation technique to the viability and quality of MSC. We will also compare the effectivity of MSC implantation from bone marrow, umbilical cord and adipose applied to non union fracture and long bone defect.

Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the cells are observed. Some of the cells are implanted directly to the patient with non union fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree Celsius in three months. All samples are thawed and the viability of the cells are observed. Patient who are implanted by MSC allogenic will undergo clinical and radiological examination in the third, sixth and twenty second month after implantation.


Condition or disease Intervention/treatment Phase
Non Union Fracture Metaphyseal Fibrous Defect Biological: MSC Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Potency of Allogenic Bone Marrow, Umbilical Cord, Adipose Mesenchymal Stem Cell for Non Union Fracture and Long Bone Defect, Directly and Cryopreserved
Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: implantation group
implantation group will receive MSC and HA-CaSo4
Biological: MSC
subjects are implanted with allogenic mesenchymal stem cells from umbilical cord/ bone marrow/ adipose




Primary Outcome Measures :
  1. cell viability [ Time Frame: 3 months ]
    percentage of cells that live divided by total cell


Secondary Outcome Measures :
  1. lower extremity functional score [ Time Frame: 3 months ]
    lower extremities functional score sheet

  2. disabilities of arm shoulder and hand [ Time Frame: 3 months ]
    disabilities of arm shoulder and hand score



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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for MSC donor

  • Bone marrow donor : Male/female aged 19-30 year without any comorbiditites (Diabetes mellitus, cardiovascular and any other autoimmune disease),HIV test Hepatitis B test and Hepatitis C test are negaitve, no fungal and bacterial contamination in the bone marrow. Subjects are willing to be aspiratied in the iliac crest in order to get the bone marrow.
  • Adipose donor : Adipose tissue are gained from liposuction or open reduction internal fixation procedure. Samples of adipose are free from HIV, Hepatitis B, Hepatitis C and free from fungal and bacterial contamination.
  • Umbilical cord donor : Umbilical cord are form elective seccio caecaria from a fullterm mother without any complications and free from HIV, hepatitis B, hepatitis C and no fungal and bacterial contamination.

exclusion / Drop out criteria

-Patients are ruled out from this study if he/she stated to do so in the time this research are held or she/he undergoes any other threatment that are not related to this study. Patient who does not show any clinical improvement in three consecutive months is categorized as failed to threat. All drop out and failed to threat patient could get other threatment.

inclusion criteria for recipient : -male/female aged 6-55 year old with bone critical defect

exclusion criteria for recipient :

-Patients with pathological fracture caused by malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppresant therapy ( chemotherapy or steroids).


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): NCT02307435


Contacts
Contact: ISMAIL H DILOGO, MD, SPOT +6221 44539917 ISMAILORTHOFKUI@YAHOO.CO.ID
Contact: PRIMA R OKTARI, MD +6281238107568 PRIMARIZKYOKTARI@GMAIL.COM

Locations
Indonesia
University of Indonesia Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10430
Contact: TRI KURNIAWATI, BSc    +6221 44539917    SELPUNCARSCM@YAHOO.CO.ID   
Contact: PRIMA R OKTARI, MD    +6281238107568    PRIMARIZKYOKTARI@GMAIL.COM   
Principal Investigator: ISMAIL H DILOGO, MD         
Faculty of Medicine, University of Indonesia Recruiting
Propinsi DKI Jakarta, Jakarta, Indonesia, 16424
Contact: ISMAIL H DILOGO, MD    +628129499428    ISMAILORTHO@GMAIL.COM   
Contact: PRIMA R OKTARI, MD    +6281238107568    PRIMARIZKYOKTARI@GMAIL.COM   
Principal Investigator: ISMAIL H DILOGO, MD         
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: ISMAIL H DILOGO, MD integrated unit of stem cell and medical technology CIPTO MANGUNKUSUMO GENERAL HOSPITAL, FACULTY OF MEDICINE UNIVERSITI OF INDONESIA, INDONESIA
Principal Investigator: ismail h dilogo, MD Indonesia University

Publications of Results:

Other Publications:

Responsible Party: Ismail Hadisoebroto Dilogo, orthopaedic medical doctor, Indonesia University
ClinicalTrials.gov Identifier: NCT02307435     History of Changes
Other Study ID Numbers: ISMMSC001
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Ismail Hadisoebroto Dilogo, Indonesia University:
non union fracture
bone defect
mesenchymal stem cell
cryopreservation

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Fibroma
Wounds and Injuries
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms