ADIPOA - Clinical Study

• ClinicalTrials.gov Identifier: NCT01585857
• Recruitment Status: Completed
• First Posted: April 26, 2012
• Last Update Posted: December 4, 2014
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Tracking Information

• First Submitted Date: March 19, 2012
• First Posted Date: April 26, 2012
• Last Update Posted Date: December 4, 2014
• Study Start Date: April 2012
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2012)

Recording of Serious Adverse Events [ Time Frame: during 365 days following injection ]

Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 24, 2012)

• Functional status of the knee [ Time Frame: during 365 days following injection ]
  Efficacy will be assessed by measuring:

  • WOMAC (Western Ontario and McMaster Universities osteoarthritis index),
  • Short Arthritis assessment Scale (SAS),
  • range of motion of the target knee joint,
  • imaging through MRI evaluation, dGEMRIC and T1rho MRI.
• Quality of life [ Time Frame: during 365 days following injection ]
  Quality of life will be assessed by measuring:

  • pain-specific assessment
  • global patient assessment (visual analog scale, Short-Form 8)
  • decrease in rescue paracetamol medication.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ADIPOA - Clinical Study
• Official Title: A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint

Brief Summary

Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

• Biological: Autologous adipose derived stem cells administrated for intra-articular use
  Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
• Biological: Autologous adipose derived stem cells administrated for intra-articular use
  Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.

Study Arms

• Experimental: Group 1
  2 x 10E6 ASC intra-articular injection (5 ml)
  Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use
• Experimental: Group 2
  10 x 10E6 ASC intra-articular injection (5 ml)
  Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use
• Experimental: Group 3
  50 x 10E6 ASC intra-articular injection (5 ml)
  Intervention: Biological: Autologous adipose derived stem cells administrated for intra-articular use

• Publications *: Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noël D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2012): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

Exclusion Criteria:

• Any disease or medication affecting the bone or cartilage metabolism, including corticoids.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany

Administrative Information

• NCT Number: NCT01585857
• Other Study ID Numbers: 8606
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Montpellier
• Study Sponsor: University Hospital, Montpellier
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christian Jorgensen, MD; University Hospital, Montpellier

• PRS Account: University Hospital, Montpellier
• Verification Date: December 2014