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Evaluation of efficacy of local injection of menstrual blood-derived mesenchymal stem cells SinaBioMBcell for the treatment of chronic neuropathic diabetic foot ulcer in a phase III double-blind randomized clinical trial

Protocol summary

Study aim
Evaluation of efficacy of local injection of menstrual blood stem cells SinaBioMBcell for the treatment of neuropathic diabetic foot ulcer
Design
The clinical trial includes a control group, two-arm parallel-group, double-blind randomized, phase III concludes 80 patients. block randomization was defined by using https://www.studyrandomizer.com/.
Settings and conduct
80 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatments, debridement of necrotic and infected tissues, and foam and Alginate bandages for reduction of the pressure. For the treatment group, cells will be injected into 5 spots (one into the middle and 4 into the margins) and for the control group, normal saline will be injected into the same spots. They will be under regular supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection
Participants/Inclusion and exclusion criteria
Chronic diabetic ulcers (more than 6 weeks) grade I-II Wagner, full-thickness ulcer, area of the wound between1-8 cm2, controlled blood sugar HbA1c less than 10, patient consent, age between 30-70, no desirable response to previous treatments, exit: osteomyelitis, high blood sugar, an area more than 8cm2
Intervention groups
Intervention: treated by injection of allogenic stem cell Control: treated by injection of normal saline
Main outcome variables
Full closure of the wound, Rate of the closure, the time period of the closure, Side effect (pain, granuloma formation, infection, erythema, inflammation), Systematic reactions (fever, nausea, vomiting, allergy)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180619040147N5
Registration date: 2021-03-29, 1400/01/09
Registration timing: prospective

Last update: 2021-03-29, 1400/01/09
Update count: 0
Registration date
2021-03-29, 1400/01/09
Registrant information
Name
Maryam Darzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.darzi@ari.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-14, 1400/01/25
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of local injection of menstrual blood-derived mesenchymal stem cells SinaBioMBcell for the treatment of chronic neuropathic diabetic foot ulcer in a phase III double-blind randomized clinical trial
Public title
Evaluation of efficacy of local injection of mesenchymal stem cells for the treatment of neuropathic diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic diabetic ulcers (more than 6 weeks) grade I-II Wagner classification without osteomyelitis Full thickness ulcer The size of the wound has to be between1-8 cm2 Controlled blood sugar (HbA1c less than 10) Patient's consent and clarification on whether they may be concluded in control or treatment group Non responsive ulcers to previous medications and treatments
Exclusion criteria:
Ulcers that are classified as grade 3-4 of Wagner classification or osteomyelitis has occurred Patients that don't meet the age criteria of the study High blood sugar levels The wounds that do not include full layers of skin. The wounds healed by other standard diabetic ulcers treatment methods
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization-In order to randomly assign 80 cases to the treatment group or control group, 10 blocks of 8 cases will be defined using "https://app.studyrandomizer.com". The treatment group and control group will be identified by codes A and B, respectively. In each block, The number of patients in the treatment group is equal to the number of patients in the control group, and The situation of each block is different from the other blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted as a double-blind clinical trial study. It indicates that the patients are blind to the treatment they are receiving and the specialist in charge of applying the treatment and collecting the data is also blind to the process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Academic Center for Education, Culture and Research (ACECR)- Biomedical Research Ethics Committee
Street address
1270, Secretariat of the Ethics Committee of ACECR,Deputy Director of Research and Technology, Headquarters of ACECR, Opposite the main door of Tehran University, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1936773493
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.ACECR.REC.1399.006

Health conditions studied

1

Description of health condition studied
Treatment of chronic neuropathic diabetic foot ulcers
ICD-10 code
E11.622
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer

2

Description of health condition studied
Treatment of chronic neuropathic diabetic foot ulcers
ICD-10 code
E10.621
ICD-10 code description
Type 1 diabetes mellitus with foot ulcer

3

Description of health condition studied
Treatment of chronic neuropathic diabetic foot ulcers
ICD-10 code
E11-40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified

Primary outcomes

1

Description
Full thickness closure progress
Timepoint
Before treatment, the first, second, fourth, fifth, and sixth weeks and again on third, fourth, fifth, and sixth-months post-treatment
Method of measurement
On each evaluation period, the wounds will be measured with special devices like a ruler specialized for wound measurements.

Secondary outcomes

1

Description
Evaluation of local side effects (irritation, inflammation, pain, granulation, infection)
Timepoint
Before treatment, the first 48 hours, and again from the first week till week six of the study
Method of measurement
Clinical observation

2

Description
Evaluation of systematic side effects (skin sensitivity, fever, shivering, nausea, vomiting)
Timepoint
Before treatment, the first 48 hours, and again from the first week till week six of the study
Method of measurement
Clinical observation

3

Description
The rate of wound healing
Timepoint
Before treatment, then from first week till week six and then every month till six months post treatment
Method of measurement
Clinical observation

4

Description
Duration of complete wound healing
Timepoint
From week one, till week six, and then every month till six months post-treatment
Method of measurement
Clinical observation

5

Description
Side effects of choronic diabetic wounds on patients ( the need of antibiotics prescription and Hospitalization)
Timepoint
From week one, till week six, and then every month till six months post-treatment
Method of measurement
Clinical observation

Intervention groups

1

Description
40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the treatment group, cells will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied, and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under regular supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection. Cell product preparation: 10 healthy, married women of fertility age who have checked in Avicenna Infertility Center for their routine check-ups will be informed by a gynecologist. After informing them of the study and having their consents, on the second day of their menstruation cycle, their menstrual blood is collected by standard menstrual Diva-cups for 8-12 hours. Afterward, the samples will be placed in pre-prepared and coded tubes containing the culture medium and sent to the GMP grade clean room of Avicenna Research Institute. Mesenchymal cells will be separated and stored in the cell bank until the day of injection.
Category
Treatment - Other

2

Description
40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the control group, normal saline will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Wound and tissue repair research center of the University of Medical Sciences Academic Center for Ed
Full name of responsible person
Gholamreza Esmaeil Javid
Street address
Enghelab St, South Flestein St, Nazari St, building No.17
City
Tehran
Province
Tehran
Postal code
1417613181
Phone
+98 21 6698 9110
Email
jdjavid@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohammad-Reza Sadeghi
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969412
Phone
+98 21 2243 2020
Email
sadeghi@ari.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
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
Iranian academic center for education culture and research
Full name of responsible person
Gholamreza Esmaeil Javid
Position
Assisstant professor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Enghelab St, South Flestein St, Nazari St, building No.17
City
Tehran
Province
Tehran
Postal code
1417613181
Phone
+98 21 6698 9110
Email
djavid@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Somaieh Kazemnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
kazemnejad_s@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Somaieh Kazemnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1936773493
Phone
+98 21 2243 2020
Email
kazemnejad_s@yahoo.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
Not applicable
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