NCT03089762

Brief Summary

Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2012

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

March 15, 2017

Last Update Submit

March 23, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • WOMAC (Western Ontario and McMaster Universities Arthritis Index)

    1 year

Secondary Outcomes (1)

  • Six minute walk distance

    1 year

Study Arms (1)

SVF and PRP

EXPERIMENTAL
Biological: Intra-articular injection of SVF plus PRP

Interventions

Intra-articular injection of SVF plus PRPBIOLOGICAL

administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2

SVF and PRP

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients age 50 or older who present with symptomatic primary osteoarthritis of the knee
  • daily pain for the previous 3 months
  • analgesics usage at least once a week
  • less than 30 minutes of morning stiffness
  • WOMAC score of ≤ 75 in the target knee
  • Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2

You may not qualify if:

  • evidence of secondary knee osteoarthritis
  • severe osteoarthritis (Joint space width - JSW \< 2 mm)
  • patients with clinically significant systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bansal H, Comella K, Leon J, Verma P, Agrawal D, Koka P, Ichim T. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis. J Transl Med. 2017 Jun 19;15(1):141. doi: 10.1186/s12967-017-1242-4.

    PMID: 28629466DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 24, 2017

Study Start

February 12, 2012

Primary Completion

December 30, 2014

Study Completion

December 30, 2014

Last Updated

March 27, 2017

Record last verified: 2017-03