NCT02140528

Brief Summary

This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

May 14, 2014

Last Update Submit

April 26, 2017

Conditions

Tibial Fracture

Keywords

Allogenic adipose derived mesenchymal stem cell tibial fracture

Outcome Measures

Primary Outcomes (1)

  • Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group

    6 months

Study Arms (2)

Mesenchymal stem cell receipients

EXPERIMENTAL

Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.

Biological: Mesenchymal stem cell injection

Placebo

PLACEBO COMPARATOR

Placebo injection in the site of fracture in patients with tibia fracture.

Biological: Placebo

Interventions

Mesenchymal stem cell injectionBIOLOGICAL

Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .

Also known as: stem cell transplantation
Mesenchymal stem cell receipients
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • The presence of tibial fracture based on X ray
  • tibial fracture is limited to diaphysial

You may not qualify if:

  • Addiction
  • Pregnancy
  • liver or kidney disease or uncontrolled diabetes or heart and lung disease
  • immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Tibial Fractures

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

    Head of regenerative medicine department &cell therapy center of Royan Institute

    STUDY DIRECTOR

  • Mohsen Emaddedin, MD

    Department or regenerative medicine of Royan Institute.

    STUDY DIRECTOR

  • Aziz Ahmadi, MD

    Scientific board of Iranian Orthopedic Association

    PRINCIPAL INVESTIGATOR

  • Maedeh Ghorbani, MD

    Department of Regenerative Medicine

    PRINCIPAL INVESTIGATOR

  • Afshin Farhadi, MD

    Scientific board of Iranian Orthopedic Association

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IR(1)