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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.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Intra-articular injection of SVF plus PRP Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-articular Injection in the Knee of Adipose Derived Stromal Cells and Platelet Rich Plasma for Osteoarthritis
Actual Study Start Date : February 12, 2012
Actual Primary Completion Date : December 30, 2014
Actual Study Completion Date : December 30, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SVF and PRP Biological: Intra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2




Primary Outcome Measures :
  1. WOMAC (Western Ontario and McMaster Universities Arthritis Index) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Six minute walk distance [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bioheart, Inc.
ClinicalTrials.gov Identifier: NCT03089762     History of Changes
Other Study ID Numbers: AAH/02/12
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases