Last reviewed · How we verify

NCT03089762

Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis

Completed Phase 1 Last updated 27 March 2017
What this trial tests

Phase 1 trial testing Intra-articular injection of SVF plus PRP in Osteoarthritis in 10 participants. Completed in 30 December 2014.

Timeline
12 February 2012
Primary endpoint
30 December 2014
30 December 2014

Quick facts

Lead sponsorBioheart, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date12 February 2012
Primary completion30 December 2014
Estimated completion30 December 2014

Drugs / interventions tested

Conditions studied

Sponsor

Bioheart, Inc. — full company profile →

Who can join

50 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Injective mesenchymal stem cell-based treatments for knee osteoarthritis: from mechanisms of action to current clinical evidences.
    Lopa S, Colombini A, Moretti M, de Girolamo L. · · 2019 · cited 116× · PMID 30159741 · DOI 10.1007/s00167-018-5118-9
  2. Intra-articular injection in the knee of adipose derived stromal cells (stromal vascular fraction) and platelet rich plasma for osteoarthritis.
    Bansal H, Comella K, Leon J, Verma P, et al · · 2017 · cited 81× · PMID 28629466 · DOI 10.1186/s12967-017-1242-4
  3. Minimally Manipulated Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Systematic Review of Clinical Evidence.
    Di Matteo B, Vandenbulcke F, Vitale ND, Iacono F, et al · · 2019 · cited 67× · PMID 31485234 · DOI 10.1155/2019/1735242

Verify or expand the search:

Other recruiting trials for Osteoarthritis

Currently open trials in the same condition.

Other Bioheart, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03089762.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing