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

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ClinicalTrials.gov Identifier: NCT03089762
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Anupam Hospital
RegennMed Research and Therapeutics Delhi
Information provided by (Responsible Party):
Bioheart, Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE February 12, 2012
Actual Primary Completion Date December 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
WOMAC (Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03089762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
Six minute walk distance [ Time Frame: 1 year ]
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 Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
Official Title  ICMJE Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Biological: Intra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
Study Arms  ICMJE Experimental: SVF and PRP
Intervention: Biological: Intra-articular injection of SVF plus PRP
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2017)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2014
Actual Primary Completion Date December 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03089762
Other Study ID Numbers  ICMJE AAH/02/12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioheart, Inc.
Study Sponsor  ICMJE Bioheart, Inc.
Collaborators  ICMJE
  • Anupam Hospital
  • RegennMed Research and Therapeutics Delhi
Investigators  ICMJE Not Provided
PRS Account Bioheart, Inc.
Verification Date March 2017

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