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

This study has been completed.
Sponsor:
Collaborators:
Anupam Hospital
RegennMed Research and Therapeutics Delhi
Information provided by (Responsible Party):
Bioheart, Inc.
ClinicalTrials.gov Identifier:
NCT03089762
First received: March 15, 2017
Last updated: March 23, 2017
Last verified: March 2017
March 15, 2017
March 23, 2017
February 12, 2012
December 30, 2014   (Final data collection date for primary outcome measure)
WOMAC (Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT03089762 on ClinicalTrials.gov Archive Site
Six minute walk distance [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Osteoarthritis
Biological: Intra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
Experimental: SVF and PRP
Intervention: Biological: Intra-articular injection of SVF plus PRP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 30, 2014
December 30, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • evidence of secondary knee osteoarthritis
  • severe osteoarthritis (Joint space width - JSW < 2 mm)
  • prior intra articular injections within the previous one year prior to inclusion
  • patients with clinically significant systemic disease
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03089762
AAH/02/12
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Bioheart, Inc.
Bioheart, Inc.
  • Anupam Hospital
  • RegennMed Research and Therapeutics Delhi
Not Provided
Bioheart, Inc.
March 2017

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