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CompletedNCT01453738Updated May 12, 2016

Allogeneic Mesenchymal Stem Cells in Osteoarthritis

A Phase 2 interventional study of Ex- vivo cultured adult allogeneic MSCs and Plasmalyte-A in Osteoarthritis of Knee, sponsored by Stempeutics Research Pvt Ltd. Completed at 5 sites in India. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Stempeutics Research Pvt Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis of Knee

Keywords

  • Osteoarthritis
  • Knee
  • Stem cells
  • Mesenchymal Stem Cells
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Stempeutics Research Pvt Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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]
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Ex- vivo cultured adult allogeneic MSCs

    Single intraarticular dose of allogeneic MSCs suspended in 2-4ml Plasmalyte A followed by 2 ml of Hyaluronan

    Biological: Ex- vivo cultured adult allogeneic MSCs

  • Placebo comparator
    Plasmalyte-A

    Single intraarticular dose of 2ml Plasmalyte

    Biological: Plasmalyte-A

Interventions

  • BiologicalEx- vivo cultured adult allogeneic MSCs

    Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan

  • BiologicalPlasmalyte-A

    Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

Secondary outcomes

  1. Change from baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index -pain subscale score

    Time frame: 2 years

  2. Change from baseline in WOMAC OA stiffness index

    Time frame: 2 years

  3. Change from baseline in WOMAC OA composite index

    Time frame: 2 years

  4. Change from baseline in ICOAP (Intermittent and Constant Osteoarthritis Pain)

    Time frame: 2 years

  5. Change from baseline in radiographic (X-ray) findings of knee

    Time frame: 2 years

  6. Change from baseline in the WORMS score (Whole-Organ Magnetic Resonance Imaging Score) of knee using MRI

    Time frame: 2 years

  7. Change from baseline in arthritis pain scores on the visual analogue scale

    Time frame: 2 years

  8. Reduction in the intake of analgesic tablets from baseline

    Time frame: 2 years

07

Study locations

5 sites
  • Department of Orthopedics, M. S. Ramaiah Memorial Hospital
    Bangalore, Karnataka 560054, India
  • Department of Orthopedics, Kasturba Medical College
    Manipal, Karnataka 576 104, India
  • Seth G. S. Medical College and KEM Hospital
    Mumbai, Maharashtra 400012, India
  • Jehangir Hospital
    Pune, Maharashtra 411001, India
  • Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
    Lucknow, Uttar Pradesh 226 014, India
08

References and documents

Publications

  • Gupta PK, Chullikana A, Rengasamy M, Shetty N, Pandey V, Agarwal V, Wagh SY, Vellotare PK, Damodaran D, Viswanathan P, Thej C, Balasubramanian S, Majumdar AS. Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel(R)): preclinical and clinical trial in osteoarthritis of the knee joint. Arthritis Res Ther. 2016 Dec 20;18(1):301. doi: 10.1186/s13075-016-1195-7. PubMed 27993154 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453738
Lead sponsor
Stempeutics Research Pvt Ltd
Responsible party
Sponsor
First posted
Oct 18, 2011
Start date
Nov 2011
Primary completion
Nov 2014
Completion
Nov 2014
Last update
May 12, 2016

Study contacts

Vikas Agarwal, MD., DM
principal investigator · Department of Immunology Sanjay Gandhi Post Graduate Institute of Medical Sciences
Vivek Pandey, MS
principal investigator · Department of Orthopedics, Kasturba Medical College
Naresh Shetty, MS
principal investigator · Department of Orthopedics, M. S. Ramaiah Memorial Hospital
Shrikant Wagh, MD
principal investigator · Jehangir Hospital
Bhibas Dasgupta, MS
principal investigator · Seth G. S. Medical College and KEM Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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