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
|
|
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. |