Phase 2
N=12
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
Osteoarthritis, Knee · Knee Degenerative Disease · Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01183728 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee. — 46.9; 25.1; 24.8; 15.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous bone marrow mesenchymal stem cells (MSV) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Red de Terapia Celular
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee. |
46.9; 25.1; 24.8; 15.4; 15.8; 56.1 | — |
| SECONDARY Indication of Efficacy |
19.5; 15.4; 14.3; 13 | — |
Summary
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence). The working hypothesis proposes that MSV antiinflammatory effect will help healing of articular cartilage degeneration to a grade enough to be objectivized by questionnaires and imaging procedures. The study of quantitative changes in structure and composition of cartilage determined by MRI T2-mapping (Cartigram ) will be performed at 6, 12 and 24 months. Pain and disability will be assessed by visual analogue scale (VAS), WOMAC, Lequesne Index and evaluation of the quality of life by Short Form 36 questionnaire (SF-36) completed at 3, 6,12 and 24 months.
Eligibility Criteria
Inclusion Criteria
- Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
- Chronic knee pain with mechanical characteristics.
- No local or systemic septic process.
- Haematological and biochemical analysis without significant alterations that contraindicate treatment.
- Informed written consent of the patient.
- The patient is able to understand the nature of the study
Exclusion Criteria
- Age over 75 or under 18 years or legally dependent
- Any sign of infection
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
- Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
- Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
- Women who are pregnant or intend to become pregnant or breast-feeding
- Neoplasia
- Immunosuppressive states
- Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Data sourced from ClinicalTrials.gov (NCT01183728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.