Allogenic Mesenchymal Stem Cell for Bone Defect or Non Union Fracture

NCT02307435 | Unknown Early Phase 1

• 1 other identifier: ISMMSC001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Union Fracture; Metaphyseal Fibrous Defect

Keywords

non union fracture; bone defect; mesenchymal stem cell; cryopreservation

Outcome Measures

Primary Outcomes (1)

• cell viability

  percentage of cells that live divided by total cell

  3 months

Secondary Outcomes (2)

• lower extremity functional score

  3 months

• disabilities of arm shoulder and hand

  3 months

Study Arms (1)

implantation group

EXPERIMENTAL

implantation group will receive MSC and HA-CaSo4

Biological: MSC

Interventions

MSC BIOLOGICAL

subjects are implanted with allogenic mesenchymal stem cells from umbilical cord/ bone marrow/ adipose

implantation group

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

University of Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Faculty of Medicine, University of Indonesia

Propinsi DKI Jakarta, Jakarta Special Capital Region, 16424, Indonesia

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ISMAIL H DILOGO, MD, SPOT

CONTACT

+6221 44539917; ISMAILORTHOFKUI@YAHOO.CO.ID

PRIMA R OKTARI, MD

CONTACT

+6281238107568; PRIMARIZKYOKTARI@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopaedic medical doctor

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: December 4, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

ID (2)