Allogeneic Mesenchymal Stem Cells in Osteoarthritis

Osteoarthritis of Knee Clinical Trial

Official title:

A Randomized, Double Blind, Multicentric, Placebo Controlled, Phase -II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients With Osteoarthritis of Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453738
• Other study ID #: SRPL/OA/09-10/001
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2011
• Last updated: May 11, 2016
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2016
• Source: Stempeutics Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

This trial is planed to study if allogeneic mesenchymal stem cells would be safe and beneficial in osteoarthritis of knee joint. This is a double blind study. Different doses of stem cells will be used in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Males or females in the age 40 - 70 years (both inclusive)

2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.

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

4. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.

5. Patients who have been on stable medication which may be NSAIDs / Opioid or opiate analgesics, for the past three months.

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

7. Ability to provide written informed consent.

Exclusion Criteria:

1. Prior or ongoing medical conditions (e.g., 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 would be completed, or could impair the assessment of study results.

2. History of surgery, or major trauma to the study joint

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

4. 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

5. Patients who had received intraarticular steroids or hyaluronan within the last three months.

6. Infections in or around the knee.

7. Patients awaiting a replacement knee or hip joint

8. Patients with other conditions that cause pain

9. Patients with deformity of the knee joint.

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

11. Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis

12. Other pathologic lesions on x-rays of knee

13. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or RPR

14. History of Bleeding disorders

15. Known hypersensitivity to Hyaluronan products or animal sera

16. For women of child-bearing potential: positive pregnancy test or lactating [Females who are planning pregnancy within next one year should be excluded]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Ex- vivo cultured adult allogeneic MSCs
Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
• Plasmalyte-A
Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

Locations

Country	Name	City	State
India	Department of Orthopedics, M. S. Ramaiah Memorial Hospital	Bangalore	Karnataka
India	Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences	Lucknow	Uttar Pradesh
India	Department of Orthopedics, Kasturba Medical College	Manipal	Karnataka
India	Seth G. S. Medical College and KEM Hospital	Mumbai	Maharashtra
India	Jehangir Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Stempeutics Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with adverse events as a measure of safety and tolerability	Safety evaluation will include assessment of physical examination, periodic monitoring of vital signs (heart rate, respiratory rate, blood pressure and temperature), clinical laboratory investigations (including haematology, serum chemistry, LFT, urine-analysis) and 12-lead ECG recording.; Tolerability: Adverse events monitored using information volunteered by the patients and as observed by the PI will be summarized descriptively by total number of AE(s) and compared between the study arms.	2 years	Yes
Secondary	Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score		2 years	No
Secondary	Change from baseline in WOMAC OA stiffness index		2 years	No
Secondary	Change from baseline in WOMAC OA composite index		2 years	No
Secondary	Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)		2 years	No
Secondary	Change from baseline in radiographic (X-ray) findings of knee		2 years	No
Secondary	Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI		2 years	No
Secondary	Change from baseline in arthritis pain scores on the visual analogue scale		2 years	No
Secondary	Reduction in the intake of analgesic tablets from baseline		2 years	No