Autologous grafting of sonicated filtered lipoaspirate in single surgical sitting without using any enzyme or chemical in treatment of Osteoarthritis.

Completed

Conditions: Patients suffering from Knee/Joint pain due to Osteoarthritis

Registration Number: CTRI/2018/02/011844

Lead Sponsor: Sahaj Regenerative Cell Therapeutics LLP

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

History of primary idiopathic osteoarthritis of knee characterized by pain of moderate intensity.
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.
Radiographic evidence of grade I to IV osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
Daily pain on activity and persistent pain despite the use of other anti-inflammatory or analgesic treatment.
Patients who have been on stable medication for past 3 months.
Able to complete 2 week washout period during which NSAIDs are prohibited.
Patients who have not received any Intra articular steroids or hyaluronic acid within the last 3 month.
The patient is able to understand the nature of the study Informed written consent provided by the patient.

Exclusion Criteria

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 investigatorâ€™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.
History of surgery, including arthroscopy or major trauma to the study joint in the previous 12 months.
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.
Infections in or around the knee.
Participation in another clinical trial or treatment with another investigational product within 30 days before inclusion in the study.
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.
Patients taking corticosteroid medicines or hyaluronic injection in the last 3 months.
Significant incapacitated or disabled and would be categorized as ACR functional Class IV (largely or wholly incapacitated), or unable to walk without assisted devices.
Patients with other known rheumatic or inflammatory disease such as RA, Gout, hepatitis or syphilis or Bleeding disorders.
Positive Hepatitis B surface antigen, Hepatitis C antibody test, Antihuman Immunodeficiency Virus (HIV) antibody test or VDRL.
Neoplasia & Immunosuppression.
For a woman of childbearing potential; +ve pregnancy test or breastfeeding.
Age >90 or <18 years or legally dependent.
Obesity, with body mass index >30 (calculated as a mass in kg/ height in m2).
Congenital or acquired diseases leading to significant knee deformities that may interfere with cell application or interpretation of results.
Other conditions that may, according to medical criteria, discourage participation in the study.
Active neoplastic disease in the previous 3 years 18.
Knee deformity more than 15 Degree Varus or valgus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety, efficacy and tolerability on the basis of adverse event	Pre operative \| One week \| One month \| Three month
VAS score	Pre operative \| One week \| One month \| Three month
KOOS score	Pre operative \| One week \| One month \| Three month

Secondary Outcome Measures

Name	Time	Method
Xray and / or MRI	pre operative and post operative

Trial Locations

Locations (2): Index Medical College Hospital and Research Center
🇮🇳
Indore, MADHYA PRADESH, India
Sahaj Hospital
🇮🇳
Indore, MADHYA PRADESH, India
Index Medical College Hospital and Research Center
🇮🇳Indore, MADHYA PRADESH, India
Dr Vinay Tantuway
Principal investigator
9826030049
vinayforever@gmail.com