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CTRI Number  CTRI/2018/02/011844 [Registered on: 12/02/2018] Trial Registered Retrospectively
Last Modified On: 12/03/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Autologous grafting of sonicated filtered lipoaspirate in single surgical sitting without using any enzyme or chemical in treatment of Osteoarthritis. 
Scientific Title of Study   Use of Autologous adipose tissue derived Stromal Vascular fraction in treatment of Knee Osteoarthritis and Chondral Lesion 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinay Tantuway 
Designation  Associate Professor 
Affiliation  Index Medical College Hospital and Research Center 
Address  Index Medical College Hospital and Research Center Department of Orthopedics Index City, Near village Khudel, Nemawar Road, NH-59A, Indore
Index Medical College Hospital and Research Center Department of Orthopedics Index City, Near village Khudel, Nemawar Road, NH-59A, Indore
Indore
MADHYA PRADESH
452016
India 
Phone    
Fax    
Email  vinayforever@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Raj Sharma 
Designation  Head Operations 
Affiliation  Sahaj Hospital 
Address  Sahaj Hospitals Department of Administration/Operations Room No. 888 15/2, South Tukoganj, Indore
Sahaj Hospitals Department of Administration/Operations Room No. 888 15/2, South Tukoganj, Indore
Indore
MADHYA PRADESH
452001
India 
Phone    
Fax    
Email  raj@sahajhospitals.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pankaj Mehtp 
Designation  Medical Coordinator 
Affiliation  Sahaj Hospital 
Address  Sahaj Hospitals Department of Administration / Operations Room No. 777 15/2, South Tukoganj, Indore
Sahaj Hospitals Department of Administration / Operations Room No. 777 15/2, South Tukoganj, Indore
Indore
MADHYA PRADESH
452001
India 
Phone    
Fax    
Email  medicalcoordinator@sahajclinic.com  
 
Source of Monetary or Material Support  
Sahaj Regenerative Cell Therapeutics LLP, 15/2, South Tukoganj, Indore, Madhya Pradesh, India 
 
Primary Sponsor  
Name  Sahaj Regenerative Cell Therapeutics LLP 
Address  15/2, South Tukoganj, Indore, Madhya Pradesh, India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinay Tantuway  Index Medical College Hospital and Research Center  Index City, Near Village Khudel, Nemawar Road, NH 59 A, Indore
Indore
MADHYA PRADESH 
9826030049

vinayforever@gmail.com 
Dr Vinay Tantuway  Sahaj Hospital  15/2, South Tukoganj, Indore
Indore
MADHYA PRADESH 
8223082444

piyush@sahajclinic.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Index Medical College Hospital and Research Center, Indore  Approved 
Sahaj Hospital  No Objection Certificate 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from Knee/Joint pain due to Osteoarthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Grafting of Stromal Vascular Fraction in knee joint  Autologous Adipose derived Stromal Vascular Fraction grafting done in a single surgical sitting for Osteoarthritis of knee 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. History of primary idiopathic osteoarthritis of knee characterized by pain of moderate intensity.
2. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400mtrs, getting in and out of a chair or going up n downstairs.
3. Radiographic evidence of grade I to IV osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
4. Daily pain on activity and persistent pain despite the use of other anti-inflammatory or analgesic treatment.
5. Patients who have been on stable medication for past 3 months.
6. Able to complete 2 week washout period during which NSAIDs are prohibited.
7. Patients who have not received any Intra articular steroids or hyaluronic acid within the last 3 month.
8. The patient is able to understand the nature of the study Informed written consent provided by the patient.

 
 
ExclusionCriteria 
Details  1. Prior or ongoing medical condition (eg: concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator’s opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up could be completed or could impair the assessment of the study results.
2. History of surgery, including arthroscopy or major trauma to the study joint in the previous 12 months.
3. Signs of active study joint inflammation including redness, warmth and/or, if qualifying with the Osteoarthritis of the knee, a large, bulging effusion of the study knee joint with loss of normal contour of the joint at the screening visit or at the baseline examination after the washout period.
4. Infections in or around the knee.
5. Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study.
6. Patients with other conditions that cause pain or Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
7. Patients taking corticosteroid medicines or hyaluronic injection in the last 3 months.
8. Significant incapacitated or disabled and would be categorized as ACR functional Class IV (largely or wholly incapacitated), or unable to walk without assisted devices.
9. Patients with other known rheumatic or inflammatory disease such as RA, Gout, hepatitis or syphilis or Bleeding disorders.
10. Positive Hepatitis B surface antigen, Hepatitis C antibody test, Antihuman Immunodeficiency Virus (HIV) antibody test or VDRL.
11. Neoplasia & Immunosuppression.
12. For a woman of childbearing potential; +ve pregnancy test or breastfeeding.
13. Age >90 or <18 years or legally dependent.
14. Obesity, with body mass index >30 (calculated as a mass in kg/ height in m2).
15. Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
16. Other conditions that may, according to medical criteria, discourage participation in the study.
17. Active neoplastic disease in the previous 3 years
18. Knee deformity more than 15 Degree Varus or valgus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety, efficacy and tolerability on the basis of adverse event
KOOS score
VAS score 
Pre operative
One week
One month
Three month
 
 
Secondary Outcome  
Outcome  TimePoints 
Xray and / or MRI  pre operative and post operative 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/05/2015 
Date of Study Completion (India) 20/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Vinay Tantuway et al, Autologous grafting of non-manipulated freshly isolated - adipose tissue derived stromal vascular fraction in single surgical sitting for treatment of knee osteoarthritis, International Journal of Research in Orthopaedics, Int J Res Orthop. 2017, Jan;3(1):107-115 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Evaluating safety and efficacy in group of patients undergoing Autologous Stromal Vascular fraction grafting done in a single surgical sitting in treatment of knee Osteoarthritis and Chondral lesions

In which isolation of Stromal Vascular Fraction is done without using Enzymes, Chemical and Animal Products

Modified KOOS clinical score was used to evaluate clinical effect and was based on pain, non-steroid

analgesic usage, limping, extent of joint movement, and stiffness evaluation before and at pre-operative, 1 Month

post-op, 6 months post-op and 12 Months post-op after grafting. No side effects, systemic infection or cancer was

associated with Autologous grafting of SVF. There was a significant improvement from pre-op to post op in all the

followed patients. Average KOOS score improved from pre-operative 46.4 to post-operative 12 months average 77.9

i.e. very significant improvement in all grades. All sub-scale parameter for pain, symptoms, activity of living and

quality of life showed significant improvement. Higher grade of OA were associated with comparatively slower

healing.

Conclusions: Autologous grafting of SVF in single surgical sitting is a novel and promising treatment approach for

patients with degenerative OA. This treatment method was found to be minimal invasive, safe and cost-effective

treatment modality for osteoarthritis.

 
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