Evaluation of the Safety and Efficacy of Transplanting an Injectable Hydrogel Carrier Laden with Mesenchymal Stem Cells for the Treatment of Patients with Diabetic Foot Ulcers: Phase 1/2 Clinical Trial (Semi-industrial Production of an Injectable MSC-Loaded Hydrogel Carrier for Chronic Wound Therapy)
Evaluation of the safety of the hydrogel carrier containing cells in the treatment of diabetic wounds
Evaluation of the efficacy of the hydrogel carrier containing cells in the treatment of diabetic wounds
Introduction of a novel therapeutic approach for chronic wound repair
Assessment of the cost-effectiveness of hydrogel carrier containing cells therapy versus standard treatment
Evaluation of the risk of late complications, including recurrent infection and amputation
Design
The study will be conducted as a randomized, controlled (interventional) Phase 1/2 clinical trial in 30 patients with diabetic wounds.
Settings and conduct
ACECR - Khorasan Razavi
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Adults with type 1 or type 2 diabetes and a non-healing foot ulcer of at least 4 weeks duration
Diabetic foot ulcer classified as Wagner grade 1 or 2
Ankle–brachial index (ABI) ≥ 0.7
HbA1c < 12 %
Wound area between 2 and 20 cm²
No concurrent use of medications known to impair wound healing (e.g. corticosteroids, immunosuppressants, cytotoxic agents)
Exclusion Criteria:
Current use of corticosteroids, immunosuppressive drugs, or cytotoxic agents
Pregnancy or breastfeeding
Renal failure (serum creatinine > 3 mg/dL)
Heart failure
Uncontrolled systemic infection
Age > 80 years
Neuropathic disorders other than diabetic neuropathy
Peripheral vascular disease
Psychiatric illness or significant cognitive/functional impairment
Intervention groups
15 patients in the intervention group (treated with the hydrogel carrier containing cells plus standard therapy
15 patients in the control group (treated with standard care - advanced dressing)
Main outcome variables
wound surface size, pain, infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250302064900N1
Registration date:2025-05-29, 1404/03/08
Registration timing:prospective
Last update:2025-05-29, 1404/03/08
Update count:0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Halimeh Hassanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3199 7451
Email address
h.hassanzadeh@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Safety and Efficacy of Transplanting an Injectable Hydrogel Carrier Laden with Mesenchymal Stem Cells for the Treatment of Patients with Diabetic Foot Ulcers: Phase 1/2 Clinical Trial (Semi-industrial Production of an Injectable MSC-Loaded Hydrogel Carrier for Chronic Wound Therapy)
Public title
Evaluation of the Effect of an Injectable Hydrogel Carrier Containing Stem Cells on Diabetic Foot Ulcer Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with type 1 or type 2 diabetes who have had non-healing wounds for at least four weeks
Diabetic ulcer grade 1–2 on the Wagner scale; ankle-brachial index (ABI) ≥ 0.7; HbA₁c < 12 %; wound size 2–20 cm²
No use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic drugs
Exclusion criteria:
Use of corticosteroids, immunosuppressive agents, and cytotoxic drugs
Pregnancy and breast feeding
Presence of renal failure (serum creatinine > 3 mg/dL); heart failure; uncontrolled systemic infection; neuropathic disorders other than diabetic neuropathy; peripheral vascular disease; and psychiatric illness or disability
Age over 80 years
Age
From 18 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
In this study, randomization will be conducted using a block randomization method with an allocation ratio of 1:1 (equal distribution between the two groups).
A total of 30 participants will be randomly assigned equally into two groups:
Group A: Receiving treatment with cell-loaded hydrogel
Group B: Receiving routine treatment
To maintain balance in the number of participants in each group throughout the study, blocks of four (Block size = 4) were used. There are six possible permutations of the two treatments (A and B) within a four-subject block:
AABB – ABAB – ABBA – BBAA – BABA – BAAB
The sequence of block assignments was randomly generated using the Random Allocation Software.
In total, 7 full blocks (4 participants each) and 1 final block (2 participants, with a 1:1 ratio of A to B) were designed to allocate all 30 participants.
The randomly selected treatment sequences for each block are as follows:
Block Number Randomized Treatment Sequence
1 ABAB
2 BAAB
3 AABB
4 BBAA
5 ABBA
6 BABA
7 AABB
8 (Final) AB
The final allocation of participants will be carried out upon enrollment, based on the predefined sequences. Allocation concealment will be ensured by a person not involved in the execution of the study.
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
Ethics Committee of Mashhad ACECR in Biomedical Research
On days 3, 7, and 14, and then monthly for up to one year
Method of measurement
Measuring tool
2
Description
wound healing rate
Timepoint
On days 3, 7, and 14, and then monthly for up to one year
Method of measurement
macroscopic evaluation
3
Description
Severity of wound pain
Timepoint
On days 3, 7, and 14, and then monthly for up to one year
Method of measurement
Pain score on a numeric rating scale
Secondary outcomes
1
Description
Survival Risk Percentage
Timepoint
day 365
Method of measurement
Plotting the survival curve
2
Description
Risk of Amputation
Timepoint
12 months after intervention
Method of measurement
Clinical Documentation
3
Description
Wound-Related Quality of Life Index
Timepoint
3 months after intervention
Method of measurement
Wound-QoL
Intervention groups
1
Description
Intervention group: Recipients of two million mesenchymal stem cells in a hydrogel carrier.
Category
Treatment - Drugs
2
Description
Control group: Recipients of standard treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ACECR- Khorasan Razavi
Full name of responsible person
Halimeh Hassanzadeh
Street address
Stem Cells and Regenerative Medicine Research Group, ACECR, Azadi Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949367
Phone
+98 51 3199 7453
Email
malihehhassanzadeh748@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Masoud Golestanipour
Street address
ACECR, Azadi Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949367
Phone
+98 51 3199 7401
Email
M.Golestanipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Halimeh Hassanzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
ACECR, Azadi Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949367
Phone
+98 51 3199 7453
Email
malihehhassanzadeh748@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadi Hosseinian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Azadi Sq.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 521 4159
Email
hoseinianh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mahboubeh Kazemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Stem Cells and Regenerative Medicine Group, ACECR, Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۹۳۶۷
Phone
+98 51 3199 7453
Email
mahboobeh.kazemi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data - such as information related to the primary outcome or similar measures - can be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
the researchers of accademic centers
Under which criteria data/document could be used
The applicant must submit a detailed proposal including the objectives, hypotheses, methodology, and the Statistical Analysis Plan (SAP).
The proposal must be approved by the internal review committee (or ethics board) before any data are released.
A commitment not to attempt to re-identify individual participants.
The permissible scope of analyses (e.g., only descriptive analyses or pre-specified hypothesis tests).
A prohibition on using the data for commercial purposes or product development without a separate agreement.
An obligation to cite the data source in any publication or presentation.
The applicant must submit the final analysis report and any resulting manuscripts or presentations to the core team within a specified timeframe (e.g., six months).
From where data/document is obtainable
Mahboubeh Kazemi
What processes are involved for a request to access data/document
Administrative review
Scientific and ethics review
Negotiation and signing of the Data Use Agreement (DUA)
Data preparation and transfer setup