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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089762
• Other study ID #: AAH/02/12
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2017
• Last updated: March 23, 2017
• Start date: February 12, 2012
• Est. completion date: December 30, 2014

Study information

• Verified date: March 2017
• Source: Bioheart, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 30, 2014
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• Intra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Bioheart, Inc.	Anupam Hospital, RegennMed Research and Therapeutics Delhi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC (Western Ontario and McMaster Universities Arthritis Index)		1 year
Secondary	Six minute walk distance		1 year