To investigate the bone regeneration efficacy of NMImETIC peptide nanofibers
To assess callus formation before and after the application of NMImETIC peptide nanofibers
Design
This study is a prospective Phase 1 clinical trial. The study population will include patients presenting with impaired bone healing at the fracture site. Based on the study conducted at the Royan Institute (NCT Identifier: NCT01210950), a sample size of 6 patients was determined, with outcomes compared between pre- and post-intervention assessments. This is a non-randomized, open-label study, meaning neither patients nor surgeons are blinded to the treatment
Settings and conduct
Patients presenting with impaired bone healing will receive an injection of NMImETIC peptide nanofibers at the defect site at Omid Hospital or Dr. Mottalebizadeh’s clinic.
1. Infection and pain intensity at 2 weeks
4 months follow-up:
2. Callus formation: AP and lateral radiographic projections
3. Quantitative evaluation: RUST Score
4. Delayed and Nonunion
Participants/Inclusion and exclusion criteria
Inclusion
1. Age: 18 to 70 years.
2. Gender: Both males and females.
3. Clinical history: Patients who underwent MTN surgery and exhibited 4. suboptimal bone healing at the 4-month post-operative follow-up.
Compliance: Willingness to participate in and adhere to all phases of the study protocol.
Exclusion
Alcohol consumption.
Pregnancy or lactation.
Uncontrolled diabetes mellitus.
Autoimmune or immunodeficiency disorders.
Medical conditions that could interfere with study outcomes
A history of intravenous bisphosphonate therapy.
Malignancy (cancer) or current chemotherapy treatment.
Conditions related to calcium malabsorption.
Tobacco use
Intervention groups
In this study, NMImETIC Peptide Nanofibers will be used in individuals with leg length discrepancy who have not responded to bone repair.
Main outcome variables
Bone Regeneration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210526051407N3
Registration date:2026-10-30, 1405/08/08
Registration timing:prospective
Last update:2026-10-30, 1405/08/08
Update count:0
Registration date
2026-10-30, 1405/08/08
Registrant information
Name
Shima Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4722
Email address
tavakol.sh@iums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2027-09-29, 1406/07/07
Expected recruitment end date
2027-09-29, 1406/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial study of bone repair product NMImETIC Peptide Nanofibers in Patients with Leg Length Discrepancy
Public title
Clinical trial study of bone repair product NMImETIC Peptide Nanofibers in Patients with Leg Length Discrepancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-70 year-old
Men and women
Patients who underwent MTN surgery and exhibited inadequate bone healing after a 4-month follow-up period
Willingness to participate in all phases of the study
Patient with Leg Length Discrepancy
Exclusion criteria:
Alcohol consumption
Pregnancy or lactation
Uncontrolled diabetes mellitus
Autoimmune or immunodeficiency disorders
Medical conditions that could interfere with study outcomes (e.g., neurological, psychiatric, or infectious diseases).
Current use of oral bisphosphonates or a history of intravenous bisphosphonate therapy
Malignancy (cancer) or current chemotherapy treatment.
Conditions related to calcium malabsorption
Tobacco use
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14496145230
Approval date
2026-09-13, 1405/06/22
Ethics committee reference number
IR.IUMS.REC.1405.359
Health conditions studied
1
Description of health condition studied
Compromised bone regeneration
ICD-10 code
M84.36
ICD-10 code description
Stress fracture, tibia and fibula
Primary outcomes
1
Description
Bone regeneration
Timepoint
Before intervention and 4 months after intervention
Method of measurement
X-Ray
Secondary outcomes
1
Description
Pain and Infection
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
VAS and observationa
Intervention groups
1
Description
Intervention group: Single-dose percutaneous injection of NMImETIC Peptide Nanofibers bone-graft product (Tavakol BioMimetic Technologies Co) at the fracture site
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Nader Motalebizadeh Clinic
Full name of responsible person
Dr. Nader Motalebizadeh
Street address
No 73, North sheikh bahaei street, Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 902 361 4037
Email
nanomimetic@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Dr. Nader Motalebizadeh
Street address
Tehran, Jannatabad Central, North Shahin St., Kabiri Tameh St., Bahar St, NO 15
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 902 361 4037
Email
nanomimetic@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa
Street address
Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
safa.m@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
۱۴۰۴-۴-۲۰-۳۶۰۰۴
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
14
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
2
Sponsor
Name of organization / entity
Tavakol BioMimetic Technologies
Full name of responsible person
Dr. Shima Tavakol
Street address
Tavakol BioMimetic Technologies Company, Iranian Research Organization for Science and Technology, Ahmad Abad-E- Mostovfi, Tehran
City
Tehran
Province
Tehran
Postal code
3313193685
Phone
+98 902 361 4037
Email
nanomimetic@gmail.com
Web page address
http://nanomimetic.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tavakol BioMimetic Technologies
Proportion provided by this source
86
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Tavakol
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Iran University of Medical Sciences, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 913 361 4037
Email
nanomimetic@gmail.com
Web page address
http://nanomimetic.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Tavakol
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Iran University of Medical Sciences, Next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 913 361 4037
Email
nanomimetic@gmail.com
Web page address
http://nanomimetic.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Tavakol
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Iran University of Medical Sciences, Next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 913 361 4037
Email
nanomimetic@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
Yes - There is 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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Published paper
When the data will become available and for how long
3 months after paper publication
To whom data/document is available
Published paper will be available for all groups
Under which criteria data/document could be used
Only published paper will be available.
From where data/document is obtainable
published paper
What processes are involved for a request to access data/document