Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01453738
Other study ID # SRPL/OA/09-10/001
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03274713 - Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis N/A
Completed NCT04535596 - Blood Flow Restriction Exercises and Conservative Exercises in Knee Osteoarthritis N/A
Completed NCT03918291 - Whole-body Vibration Training on Functional Performance of the Elderly With Knee Osteoarthritis N/A
Recruiting NCT06263517 - Clinical Trial to Assess Efficacy, Tolerability of Rising Doses of Clodronate in Painful Knee Osteoarthritis Patients Phase 2/Phase 3
Active, not recruiting NCT01027819 - Comparison of Outcomes in Mobile and Fixed-bearing Total Knee Arthroplasty Phase 4
Completed NCT01186211 - Feasibility of Outpatient Total Knee Arthroplasty
Active, not recruiting NCT00261066 - Outcome Following Orthopaedic Surgery
Completed NCT03484910 - Biofeedback With Cycling Exercise in OA Knee Patients N/A
Recruiting NCT03884374 - Pain Relief for OsteoArthritis Through Combined Treatment (PROACT) N/A
Completed NCT03492320 - Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Completed NCT01449552 - Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT N/A
Completed NCT06254976 - Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis N/A
Completed NCT03428893 - Mobile Technology to Support Physical Therapy Exercise N/A
Completed NCT05081921 - Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases Phase 1/Phase 2
Completed NCT02850068 - Geniculate Artery Embolization for the Treatment of Knee Pain N/A
Active, not recruiting NCT03110172 - Short-term Efficacy of Antidepressant in Patients Underwent TKA Phase 1/Phase 2
Enrolling by invitation NCT02623660 - Microcurrent Stimulation Reduces Post-Operative Swelling and Healing Time Following Knee Replacement Surgery N/A
Completed NCT02579174 - Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation N/A
Completed NCT00790985 - Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee N/A
Recruiting NCT02722772 - Efficacy of Intra-Articular Injection of Etanercept for Moderate and Severe Knee Osteoarthritis N/A