1. TO STUDY THE SAFETY AND
EFFICACY OF ADIPOSE TISSUE
DERIVED MESENCHYMAL
STROMAL CELL FRACTION IN
THE MANAGEMENT OF
DIABETES MELLITUS TYPE 2
DR. YAMINI RANA
JUNIOR RESIDENT-II
DEPT. OF GENERAL SURGERY
GSVM MEDICAL COLLEGE
2. CHIEF SUPERVISOR
DR. SANJAY KALA
MS (GENERAL SURGERY)
PRINCIPAL AND DEAN
DEPARTMENT OF GENERAL SURGERY
GSVM MEDICAL COLLEGE,
KANPUR
3. CO-SUPERVISORS
DR. B.S. RAJPUT Consultant Orthopedic & Stem cell
transplant Surgeon, Mumbai.
DR. SAURABH AGRAWAL MD (Medicine) Professor
Department of Medicine, GSVM Medical College, Kanpur.
DR. VISHAL GUPTA MD (Medicine) Professor Department of
Medicine, GSVM Medical College, Kanpur.
DR. LUBNA KHAN MD (Pathology) Professor Department of
Pathology, G.S.V.M. Medical College, Kanpur
DR. TANU MIDHA MD (Community Medicine) Professor
Department of Community Medicine, G.S.V.M. Medical
College, Kanpur
4. INTRODUCTION
India is often referred to as the ‘Diabetes Capital
of the World’ as it accounts for 17% of the total
number of diabetic patients in the world.
There are currently close to 77 million people
living with diabetes in India and this number is
expected to increase to 135 million by 2045.
77.6% of India’s diabetic patients could have
uncontrolled diabetes.
According to ICMR report, the prevalence of
diabetes in India has increased by 64% over the
quarter century.
5. OBJECTIVES
PRIMARY OBJECTIVE
To establish the safety and efficacy of Adipose
Tissue Derived Cell Fraction in the management of
diabetes mellitus type 2.
SECONDARY OBJECTIVE
To evaluate the effect of Adipose Tissue Derived
Cell Fraction on Micro and Macro Vascular
complications produced as a result of diabetes
mellitus type 2.
To study the duration of efficacy and its effect on
micro and macrovascular complications.
6. MATERIALS & METHODS
The study will be conducted on the patients
admitted in the Surgery department of LLR
Hospital, GSVM Medical College, Kanpur.
Duration : 2022-24
Type of study : Prospective longitudinal study
Sample size : 30 cases
Place : Department of Surgery GSVM Medical
College, LLR & Associated Hospitals, Kanpur
7. SAMPLE SIZE
Sample Size : In previous literature, a case series was reported
about 7 diabetic patients who had undergone stem cell
therapy. (Ref. HSOA Journal of Stem Cells Research,
Development and Therapy)
The standard deviation of the difference in fasting blood
glucose levels before and after stem cell therapy was
calculated to be 41.3mg/dl. The sample size will be calculated
for a precision of 15mg/dl at 95% level of significance using
the formula.
n = the sample size will be calculated as follows:
3.84 x 41.3 x 41.3 / (15 x 15)=29.1
(n=1.96 x 1.96 x σ x σ / P x P )
At 95% level of significance, Z = 1.96
σ - Standard Deviation
P - Precision
8. INCLUSION CRITERIA
Patients with either sex with age between
25 to 60 years.
Patients with known diabetes mellitus
type 2 for more than 2 years and
maximum up to 20 years
Patients with type 2 diabetes mellitus with
HBA1C between 7-10%
Patients with serum creatinine less than 2
mg/dl.
9. EXCLUSION CRITERIA
Patients with history of taking Corticosteroids, NSAIDs and
Glycosaminoglycan.
Patients suffering from acute cardiac or respiratory condition.
Patients positive for markers for Hepatitis B, C, or HIV.
Patients with history of allergic reactions.
Patients with serum creatinine more than 2 mg/dl
Patients who have previously received stem cell therapy.
Patients with HBA1C less than 7 and more than 10
Patients less than 25 years of age or more than 60 years.
Patients with established duration of diabetes mellitus type 2
for less than 2 years.
Patients having multiple abdominal operation scars.
Pregnant and lactating females.
Patients having existing Hernia in abdomen such as incisional,
umbilical, etc
10. METHODS
Convenient sample of 30 patients will be taken.
Patient will continue the treatment for diabetes as
prescribed by the physician but if he/she gets benefit with
above treatment then doses might be adjusted as per
physician.
Statistical Analysis :
Statistical analysis will be performed using statistical
package for the social sciences (SPSS)version 21.0.C.
11. PROCEDURE AND EQUIPMENTS
Video and written informed consent will be taken from the
patient prior to the procedure.
About 300 to 400cc of adipose tissue will be aspirated by a
trained plastic surgeon with specially designed aspiration
cannulae under local anesthesia and sedation from lower
abdomen and will be processed to obtain mononuclear
cells. Mononuclear cells will be divided into two parts.
Half of the mononuclear cells (SVF- Stromal Vascular Factor)
will be injected intramuscularly (dosage: 1-2 million cells
per kg/body weight) and the other half will be processed
for culture. The pure cultures of MSCs will be passaged
twice to get more number of cells.
12. The protocol for MSCs isolation was
established by phenotypic characterization of
MSCS by surface markers. About 2 million/kg
of ADMSCs will be translated to ICAs( Islet like
Cluster Aggregates).
50% of the ADMSCs will be injected
intramuscularly and 20% will be injected i.v in
500ml NS slowly over 3 to 4 hours. Patient will
be observed for 48 hours thereafter.
Patients will be reviewed during follow up
period of 1 month and then every 3rd month.
Flow cytometer will be used for evaluating
number and viability of the cells in the
pathology department of LLRH, Kanpur.
13. EQUIPMENTS TO BE USED:
USG CAVITATOR
PLASMA CENTRIFUGE MACHINE
BIOSAFETY CABINET
FLOW CYTOMETER
FOLLOW UP
Number of sessions :
Maximum upto 3 sessions will be given and
patient will be reviewed during follow up period of
1 month and then every 3rd month till 1 year.
14. WORKING PROFORMA
Name
Age/sex
Address
Urban/Rural dweller
Past History
Personal history
Family history
Drug history for diabetes and any other drug history
Duration of Diabetes
History of any Associated Co-morbidities
Socio-economic status General examination
Pulse rate
Blood pressure
Respiratory rate
Spo2
17. ECG
CHEST X RAY
2D ECHO
OPHTHALMOSCOPY
24HR URINARY PROTEIN AND
MICROSCOPY
CLINICAL ASSESSMENT FOR PERIPHERAL
NEUROPATHY AND EMG NCV IF
REQUIRED
COLOUR DOPPLER
ABI
USG WHOLE ABDOMEN
