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Trial record 52 of 123 for:    stem cell arthritis AND Phase

Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03602872
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Clinica Santa Clarita, Mexico

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date January 30, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
Safety evaluation of all AE/SAEs [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
All AE/SAE will be assessed for causality and reported utilizing MedDRA terminology.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03602872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Procedure tolerance (procedure pain/discomfort incidence) [ Time Frame: 7 days after subject receives dosing ]
    The procedure tolerance will be evaluated through a questionnaire for procedure pain/discomfort incidence.
  • WOMAC questionnaire [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
    The WOMAC questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
  • OAKHQOL questionnaire [ Time Frame: From the first dosing of the first subject up to 30 days after the last follow up of the last dosed subject ]
    The OAKHQOL questionnaire will be used to evaluate any preliminary efficacy findings throughout the study completion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells in Subjects With Osteoarthritis
Official Title  ICMJE Phase I, Open Label Study to Assess the Safety and Tolerance of a Single Intraarticular Dose of STEMEDICA's Human Allogeneic Bone Marrow Derived Mesenchymal Stem Cells, in Subjects With Knee Osteoarthritis.
Brief Summary The aim of this study is to assess the safety of Stemedica's mesenchymal stem cells in patients with knee osteoarthritis. The route of administration is intraarticular. Safety will be evaluated by AE/SAE incidence and administration tolerance. The subjects will undergo follow-up for 52 weeks. The target population is subjects with knee osteoarthritis (grade II-III in Kellgren-Lawrence scale).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Biological: Human allogeneic mesenchymal bone marrow derived stem cells
Intraarticular administration of 20x10^6 MSCs
Study Arms  ICMJE
  • Experimental: Group 1
    Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint.
    Intervention: Biological: Human allogeneic mesenchymal bone marrow derived stem cells
  • Experimental: Group 2
    Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint.
    Intervention: Biological: Human allogeneic mesenchymal bone marrow derived stem cells
  • Experimental: Group 3
    Subjects will receive a single intraarticular 20x10^6 dose of Human allogeneic mesenchymal bone marrow derived stem cells, in the most symptomatic target (knee) joint.
    Intervention: Biological: Human allogeneic mesenchymal bone marrow derived stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
180
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2018)
20
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female volunteers between 35-65 years.
  • X-ray evidence of osteoarthritis (grade II-III in Kellgren-Lawrence).
  • Chronic joint pain (>5 visual analogue scale) in knee.
  • BMI ≤ 29.
  • Voluntary acceptance and signature of informed consent.
  • Willing to attend study visits and lab sample recollection.
  • Lab values within normal reference values.
  • Willing to use effective birth control methods.

Exclusion Criteria:

  • Inflammatory arthritis.
  • Generalized infection.
  • Active cancer or history of cancer in the past 5 years.
  • Receiving oral or intraarticular steroids.
  • Positive labs for HIV, Hepatitis B or C.
  • Recent trauma in the target joint.
  • Debris in joint.
  • Subjects that have undergone or need to undergo arthroscopic knee surgery in the target joint.
  • History of joint substitution, intraarticular fractures, osteotomy, arthroplasty or menisectomy.
  • Clinically significant knee misalignment.
  • Other illnesses that the investigator considers clinically significant.
  • Participating in another clinical trial three months before enrolling.
  • Women that are pregnant, lactating or result positive in the pregnancy test during screening.
  • Known allergies to bovine products.
  • Subjects taking anticoagulants.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vanessa Felix, Dr. (52) 664-231-7220 vfelix@clinicasantaclarita.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03602872
Other Study ID Numbers  ICMJE PRO-OAR-BW-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clinica Santa Clarita, Mexico
Study Sponsor  ICMJE Clinica Santa Clarita, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José F Izquierdo, M.D. External
PRS Account Clinica Santa Clarita, Mexico
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP