A clinical trial to evaluate the effects of stem cells in patients with Osteoarthritis of the Knee joint

Phase 3

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of the Knee joint

• Registration Number: CTRI/2018/09/015785
• Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Males or females in the age 40 ââ?¬â?? 65 years (both inclusive)

2. History of primary osteoarthritis of the knee characterized by pain which requires intake of analgesics

3. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 meters, getting in and out of a chair, getting up from squatting or cross leg position or going up and down stairs

4. Patient on analgesic medication for OA, for 6 weeks based on Investigatorââ?¬•s feedback.

5. Radiological criteria

X-ray knee joint showing radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria (based on site radiologist report).

6. Willing to refrain from any other stem cell treatment for 2 year during the study.

7. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study

8. Willing to provide written informed consent including audio-video consent

Exclusion Criteria

1. X-ray (evaluated by central radiologist) showing any of the following:

a. Grade 0, 1 and 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria

b. Subchondral sclerosis

2. MRI knee (evaluated by central radiologist) showing any of the following:

a. ACL/ PCL tears

b. Meniscal tears: Grade 3 tears - defined as increased signal intensity on PD sequences extending up to either articular surface. It also includes root tear but excludes RAMP tear

c. Patients with exclusive patello-femoral arthritis

d. Grade 0, 1 and 4 arthritis as per the proposed grading on MRI

3. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition), alcoholism, smoking, tobacco chewing or drug abuse, medical history, physical findings, ECG findings or laboratory abnormality that, in the investigatorââ?¬Ë?s opinion could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results

4. History of surgery or major trauma to the study joint

5. Arthroscopy on the study joint in the previous 12 months

6. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination

7. Acute exacerbations of the study joint in the past 6 weeks

8. Patients who had received intra-articular steroids or hyaluronan within the last 3 months

9. Patients who had taken any stem cell treatment in the past by any route of administration

10. Infections in or around the study knee

11. Patients awaiting a replacement of knee or hip joint

12. Patients with other conditions that cause pain in the knee joint

13. Patients with gross deformity (varus by x-ray of the knee or flexion deformity > 10�° by gonometer) of the knee joint based on PI judgment

14. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices

15. Patients with any secondary causes of arthritis e.g. rheumatoid arthritis, systemic lupus erythematous, ulcerative colitis, psoriasis, rheumatic or inflammatory disease

16. Patients with BMI �30 kg/m2

17. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus ââ?¬â?? I & II (HIV ââ?¬â?? I & II) antibody test, TPHA or CMV (IgM)

18. History of Bleeding disorders

19. Known hypersensitivity to hyaluronan products or animal sera or constituents of IMP

20. Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo armTimepoint: 1 year

Secondary Outcome Measures

Name	Time	Method
To assess the change from baseline to two year in WOMAC <br/ ><br>To assess the change from baseline to one year and two years follow-up as compared to the placebo arm in <br/ ><br> 1. WOMAC OA Pain Index <br/ ><br> 2. WOMAC OA Stiffness Index <br/ ><br> 3. WOMAC OA Physical Function Index <br/ ><br>Patients Assessment of Osteoarthritis Pain by VAS <br/ ><br>Assess the quality of articular cartilage by T2 mapping <br/ ><br>Cartilage thickness-MRI <br/ ><br>Cartilage volume-MRI <br/ ><br>Reduction in intake of analgesicsTimepoint: 2 years