Investigation effects and safety of collagen scaffold reinforced with polyglycolic acid and mesenchymal stem cells harvested from the iliac crest in comparison with the iliac bone graft on the healing process of scaphoid fractures in young male patients (20 to 30 years)
The aim of the present study was to investigate the effects of collagen / poly glycolic acid scaffolds in combination with bone marrow autologous mesenchymal stem cells on bone repair in patients with orthopedic disorders such as nonunion and delayed union bone
Design
Clinical trial with intervention group, community-based and pragmatic, with parallel group design, non-blind, non-random
Settings and conduct
Collagen scaffold with polyglycolic acid fiber seeded by autologous bone marrow stem cells were implanted at the non-union site and its regenerative effects are investigated.
Ten patients participate in the study (5 people in control group and 5 person in intervention group).
Location of study: Department of Orthopedics, Imam Reza Hospital, Mashhad, Iran
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Every patient with non union fracture in the scaphoide bone;
Age between 18- 60 years old;
No infection in site of surgery;
Be able and willing to participate in the study;
Written informed consent;
Non inclusion criteria:
Evidence of malignancy;
Pregnancy or breastfeeding;
Patient by positive serology or PCR for HIV; hepatitis B or C infection; the patient with accompanied fracture such as hip fracture that could not bear weight
Intervention groups
Intervention group: Use of collagen scaffold with glycolic acid fibers and bone marrow stem cell.
Control group: Use of bone graft from iliac crest (current standard method of non-union treatment)
Main outcome variables
The rate of bone formation; The rate of callus tissue formation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181222042074N1
Registration date:2020-09-03, 1399/06/13
Registration timing:retrospective
Last update:2020-09-03, 1399/06/13
Update count:0
Registration date
2020-09-03, 1399/06/13
Registrant information
Name
Shirin Toosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 2825
Email address
tusi1063@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-09-08, 1398/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation effects and safety of collagen scaffold reinforced with polyglycolic acid and mesenchymal stem cells harvested from the iliac crest in comparison with the iliac bone graft on the healing process of scaphoid fractures in young male patients (20 to 30 years)
Public title
Repair of bone fractures with scaffold and stem cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with non-union fractures in Scaphoid bone
Age between 18 and 60 years old
No infection at the fracture site
Patient availability for postoperative examinations
Fill conscious awareness
Individuals who want to refer for postoperative follow-up
Exclusion criteria:
Patients with other diseases, such as cancer.
Patients with other associated motor injuries preventing normal ability.
patients with infectious non-union fracture.
Pregnant patients
Patients have a positive HIV-positive serology or hepatitis B and C.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of vice chancellor of research Mashhad University of Medical Sciences
Street address
Central building of Mashhad University of Medical Sciences (Qoreishi), Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9183773193
Approval date
2017-04-16, 1396/01/27
Ethics committee reference number
IR.MUMS.SP.1396.124
Health conditions studied
1
Description of health condition studied
non-union scaphoid fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of bone formation
Timepoint
Before the intervention and 1, 3 and 6 months after surgery
Method of measurement
1-Quick DASH, PRWE, Wrist Mayo Clinic 2- Flexion, Extension, Supination, Pronation, Ulnar & radial deviations 3- CT scan before and after surgery 4-Radiography
2
Description
The rate of callus tissue formation
Timepoint
Before the intervention and 1, 3 and 6 months after surgery
Method of measurement
Radiographs and CT scans
Secondary outcomes
1
Description
Time duration of union
Timepoint
2 weeks, 3 months and 6 months after intervention
Method of measurement
Days, X-ray, physical examination
2
Description
Nonunion
Timepoint
6 months after intervention
Method of measurement
X-Ray, physical examination
3
Description
Surgical site infection
Timepoint
2 days, 2 weeks, 3 months after intervention
Method of measurement
physical examination, ESR and CRP lab tests
4
Description
duration of anesthesia
Timepoint
at the time of operation in operating room
Method of measurement
inspection
5
Description
pain
Timepoint
before, 3 and 6 months after surgery
Method of measurement
Visual Analog Scale (VAS)
6
Description
Function
Timepoint
before, 3 and 6 months after surgery
Method of measurement
Lower Extremity Functional Score (LEFS)
Intervention groups
1
Description
The control group: gets standard treatment with placement of iliac bone graft in site of non-union.
Category
Treatment - Devices
2
Description
Intervention group: Collagen / Polyglycolic acid scaffold with a weight ratio of 0.5 prepare. Bone marrow aspiration from the iliac crest is performed with a Jamshidi needle under local anesthesia, and the mesenchymal stem cells (MSCs) taken from each individual are transferred to a laboratory and cultured in the clean room. The cell will be used in passage 1, then MSCs seed into sponge and will be placed during surgery into scaphoid fracture. The healing process is assessed 1,3 and 6 months after surgery.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad, Imam Reza hospital
Full name of responsible person
Javad Behravan
Street address
Imam Reza hospital, Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3882 3255
Email
Tusi1063@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences (Qoreishi), Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 1841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
66
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shirin Toosi
Position
Postdoc Student
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Biotechnology Research Center, School of Pharmacy, Ferdowci University, Park Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3882 3255
Email
tusi1063@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Behravan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical Biotechnology
Street address
Biotechnology Research Center, School of Pharmacy, Ferdowci University, Park Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3882 3255
Email
behravanj@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shirin Toosi
Position
Postdoc Student
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
Biotechnology department; School of Pharmacy, Mashhad Medical University campus; Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
+98 51 3882 3255
Email
Tusi1063@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available