CTRI/2019/12/022351 [Registered on: 12/12/2019] Trial Registered Prospectively
Last Modified On:
11/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Stem Cell Therapy
Study Design
Other
Public Title of Study
A study to see the effects of stem cells in patients with Non-Healing Diabetic Foot Ulcer
Scientific Title of Study
A Label extension, Randomized, Double Blind, Placebo Controlled, Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of Peri-ulcer Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Non-Healing Diabetic Foot Ulcer
JSS Medical Research India Private Limited A-39, 5th Cross Street, Hindu Colony, Nanganallur, Chennai -600061, Tamil Nadu, India Chennai TAMIL NADU 600061 India
Chennai TAMIL NADU 600061 India
Phone
9771407484
Fax
Email
jayashri.krishnan@jssresearch.com
Source of Monetary or Material Support
Stempeutics Research Pvt. Ltd,
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli
Bengaluru – 560 048
India.
Primary Sponsor
Name
Stempeutics Research Pvt Ltd
Address
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area
K R Puram Hobli
Bengaluru – 560 048
India.
Pogathota, Nellore, Andhra Pradesh-524001, India Nellore ANDHRA PRADESH
8612326892
murthyssatyanarayana@gmail.com
Dr Ashok Damir
Dr. B L Kapur Memorial Hospital
Pusa Road, New Delhi 110005 Central DELHI
9810262600
drashok.damir@gmail.com
Dr Kapil Dev
Fortis C DOC Hospital
Lala
Lajpat Rai Road, Chirag
Enclave, Opp Devika
Tower, Nehru place,
New Delhi- 110048,
India
South DELHI
9811039775
drkapildev@hotmail.com
Dr Ghanshyam Goyal
ILS Salt Lake
4th floor,DD-6,Sector 1,Salt lake city,Kolkata-700064, West Bengal, India Kolkata WEST BENGAL
9830400450
drgsgoyal@hotmail.com
Dr Dinesh B V
Kasturba Hospital
Department of General
Surgery, Room No
6,3rd floor, New OPD
Block, Centre for
Diabetic Foot Care &
Research, MAHE
Manipal-576104,
Karnataka, India
Udupi KARNATAKA
Sri Ramachandra Institute of Higher Education & Research
Department of General Surgery, Clinical Research division, Dental college Basement, No-1, Ramachandra nagar,Porur, Chennai-600116, Tamil Nadu, India Chennai TAMIL NADU
9884256323
mohanapriyadr@gmail.com
Dr Anthony Rozario
St. Johns Medical College and Hospital
Second floor,Department of General Surgery,Sarjapur Road, Bangalore-560034, Karnataka, India Bangalore KARNATAKA
9845065218
prakashrozario7@gmail.com
Dr Preeti Gupta
Swasthyam Superspeciality Hospital
Plot no 97,98, CTO Staff co-operative Housing Society, Vivekanand Nagar, Near Sai Mandir, Wardha road Nagpur- 440015 Nagpur MAHARASHTRA
8698548509
guptapreeti084@gmail.com
Dr Smitha S Segu
Victoria Medical College & Research Institute
Bangalore Medical College & Research Institute, Room # 72/A.2nd floor, K.R. Road, Fort, Bangalore, Karnataka- 560002 Bangalore KARNATAKA
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
CryoStor® CS5)
Dose: 0.6 ml/cm2 Frequency :
Single administration
Route of administration:
Periulcer injection- intramuscular / intradermal / subcutaneous
Intervention
stempeucel®
Dose: 3 million cells / cm2 of ulcer
Frequency :
Single administration
Route of administration:Periulcer injection - intramuscular / intradermal / subcutaneous
Patients must satisfy all of the following criteria to be included in the study:
1. A signed and dated informed consent form and audio- visual consent has been obtained from the patient
2. Patient is able and willing to comply with study procedures
3. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-70 years
4. Patient has type 2 diabetes mellitus
5. HbA1c, less than or equal to 10%
6. Presence of single non-healing DFU in the target limb that meets all of the following criteria:
a) Ulcer in the plantar surface of the foot
b) Ulcer has been diagnosed as a full-thickness DFU
c) Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement at the time of screening)
d) Wagner grade 1 at initialization of the clinical trial (ulcer should not have evidence of exposed muscle, tendon, bone or joint capsule)
e) Non healing study ulcer for the duration of at least 4 weeks at the time of the screening visit (to be confirmed by the investigator during interviewing the patient- documented evidence in the form of hospital records / prescription from the doctor is required)
7. Patient has adequate vascular perfusion of the affected limb, as defined by Ankle-Brachial Index (ABI) ≥ 0.7 and < 1.3. If ABI is >1.3 then Toe Brachial Index (TBI) will be performed and TBI should be ≥ 0.5
8. Patient or responsible caregiver is willing and able to maintain the required off-loading (as applicable for the location of the ulcer) and applicable dressing changes
INCLUSION CRITERIA AT RANDOMIZATION
1. Presence of single non-healing DFU in the target limb that meets all of the following criteria:
a) Ulcer in the plantar surface of the foot
b) Ulcer has been diagnosed as a full-thickness DFU
c) Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement if clinically indicated at the time of randomization)
d) Wagner grade 1 at initialization of the clinical trial (ulcer should not have evidence of exposed muscle, tendon, bone or joint capsule)
e) Ulcer which is non infected
ExclusionCriteria
Details
Patients may not be selected if any of the following criteria are present
1. Patients with type I diabetes mellitus
2. Patients with 2 or more ulcers in the target limb
3. Patient with known hypersensitivity to the constituents of the IMP – DMSO, Dextran 40, CryoStor® - CS5
4. Pregnant and lactating women
5. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial any time in the past
6. Patient has a current or past history of any cancer
7. Patients currently undergoing dialysis (within 30 days of screening)
8. Patient is currently receiving (i.e., within 30 days of screening) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with or affect the rate and quality of wound healing (e.g., systemic steroids, anticoagulants, immunosuppressive therapy, autoimmune disease therapy, revascularization procedure in the target limb, angioplasty in the target limb or radiation therapy in the target limb).
9. Patients who have undergone thrombolysis within 30 days of screening
10. Patients with BMI > 32.5 kg/m2
11. Patients with serum albumin < 3 gm %
12. Patients with Hb < 9 gm %
13. Patients serum bilirubin level 2 times more than upper normal limit
14. Patient has any of the following unstable conditions or circumstances that could interfere with the standard care of treatment:
a) Inability to comply with treatment visit schedule
b) Mental incapacity
c) Current substance abuse
15. Patient has a history of or any of the following current illnesses or conditions (other than diabetes) which in the opinion of investigator, would compromise the safety of the patient, or the normal wound healing process:
a) End-stage renal disease (CKD stage IV or V) (patients with serum creatinine > 3 mg/dl)
b) Severe malnutrition
c) Liver disease (patients bilirubin 2 times more than upper normal limit)
d) Aplastic anemia
e) Scleroderma
f) Connective tissue disorder
g) Exacerbation of sickle cell anemia
h) Disabling cardiac disease
i) Disabling pulmonary disease
j) Excessive lymphedema
k) Unstable Charcot foot or Charcot with bony prominence
16. Positive for HIV, HCV, HBV, VDRL
17. Patient has ulcers secondary to a disease other than diabetes, e.g., vasculitis, or hematological disorders
18. Patient has clinical and radiographic (X-ray) evidence of osteomyelitis with necrotic soft bone in the target limb
19. Patient with Chopart amputation in the target limb
20. Patient has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of screening
21. Patient has been treated with hyperbaric oxygen within 5 days of screening.
22. Patient has suspected or confirmed signs/symptoms of gangrene or acute wound infection or cellulitis on any part of the affected limb. (Patients with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection; the affected limb should be clinically free of infection).
23. Patients who have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
24. Patient is an employee or blood relative of any member of the Investigational site or the Sponsor
EXCLUSION CRITERIA AT RANDOMIZATION
1. Reduction in the ulcer area by more than or equal to 30% (post debridement if clinically indicated and performed)compared to the measurement at screening visit (post debridement)
ELIGIBILITY CRITERIA BEFORE IMP ADMINISTRATION
1. Ulcer size (area) between 1 to 8 cm2 (both inclusive) (post-debridement if clinically indicated)
2. Ulcer which is non infected
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1. Proportion of patients with complete healing/closure of the target ulcer at any time during the 12 week period with sustained complete closure for 12 additional weeks of follow-up
2. Rate of reduction in size of the target ulcer during the 24 weeks of follow-up
1. 24 weeks
2. 24 weeks
Secondary Outcome
Outcome
TimePoints
Time to complete closure of target ulcer
24 Weeks
Proportion of patients with at least 50% closure of target ulcer during the 24 week period
24 Weeks
Proportion of patients with complete healing/closure of the target ulcer at any time during the 24 week follow-up period
24 Weeks
Safety endpoints:
1.The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
After the treatment
2. Assessment of clinical laboratory and ECG parameters
After the treatment
3. Physical examination findings and assessment of vital signs
After the treatment
Target Sample Size
Total Sample Size="84" Sample Size from India="84" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
ThisstudyisaRandomized, Double Blind, Placebo Controlled, Multicentre, Single Dose, Phase III Study Assessing the Efficacy and Safety of Peri-ulcer Administration of stempeucel® in Patients with Non-Healing Diabetic Foot Ulcer thatwillbeconducted in twenty two (22) centers in India.
The primary objective will be to evaluate the efficacy of periulcer administration of stempeucel® in healing of DFU.
The secondary objective will be to assess the safety of periulcer administration of stempeucel® in DFU